0.8% RESOLVE B 11X3ML
Report
- Report Number
- 2250051-2026-00012
- Event Type
- Malfunction
- Date Received
- April 11, 2026
- Date of Event
- March 4, 2026
- Report Date
- April 6, 2026
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Product Code
- QHT
- UDI-DI
- 10758750007684
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION DETAILS: THE CUSTOMER REPORTED THAT DAILY QUALITY CONTROL (QC) TESTING WAS PERFORMED AND PASSED AS EXPECTED ON THE DAYS OF TESTING. NO ADDITIONAL DETAILS WERE PROVIDED. ORTHO GTSC HAS INVESTIGATED THE STEPS OF PROCESSING THE PATIENT SAMPLES INCLUDING SAMPLE BARCODE READ, SAMPLE ASSIGNMENT IN SAMPLE RACK OF THE ANALYZERS, PIPETTING DATA, IMAGES OF THE MTS CARDS USED WITH REACTIONS OBTAINED AND THE CONCLUSION WAS THAT EVERY STEP WAS EXECUTED CORRECTLY AND ANALYZERS ISSUE CAN BE RULED OUT. ACCORDING TO ORTHO LOT-SPECIFIC INFORMATION FOR 0.8% SELECTOGEN LOT: VS767 AND VS769, CELL 1 IS NEGATIVE FOR THE E ANTIGEN, AND CELL 2 IS POSITIVE AND HOMOZYGOUS FOR THE E ANTIGEN. IT FOLLOWS THEREFORE THAT THE NEGATIVE REACTIONS OBTAINED WITH CELLS 2 OF BOTH LOTS ARE NOT CONSISTENT WITH THE EXPECTED REACTIVITY OF AN ANTI-E ANTIBODY. ACCORDING TO ORTHO LOT-SPECIFIC INFORMATION FOR 0.8% RESOLVE PANEL A LOT: VRA504, CELL 3 IS POSITIVE AND HOMOZYGOUS FOR THE E ANTIGEN AND CELL 6 IS POSITIVE AND HETEROZYGOUS FOR THE E ANTIGEN. IT FOLLOWS THEREFORE THAT THE WEAK POSITIVE REACTION OBTAINED WITH CELL 3 AND THE NEGATIVE REACTION OBTAINED WITH CELL 6 ARE CONSISTENT WITH THE EXPECTED REACTIVITY OF A WEAK ANTI-E ANTIBODY. ACCORDING TO ORTHO LOT-SPECIFIC INFORMATION FOR 0.8% RESOLVE PANEL B LOT: VRB347, CELLS 15, 16, AND 17 ARE POSITIVE AND HOMOZYGOUS FOR THE E ANTIGEN AND CELL 20 IS POSITIVE AND HETEROZYGOUS FOR E ANTIGEN. IT FOLLOWS THEREFORE, THAT THE WEAK POSITIVE REACTION OBTAINED WITH CELLS 15 AND 20 AND THE NEGATIVE REACTIONS OBTAINED WITH CELLS 16 AND 17 ARE CONSISTENT WITH THE EXPECTED REACTIVITY OF A WEAK ANTI-E ANTIBODY. AS PART OF THE INVESTIGATION, A REVIEW OF THE MANUFACTURING BATCH RECORD WAS REQUESTED FOR 0.8% SELECTOGEN LOTS: VS767 / VS769, 0.8% RESOLVE PANEL A LOT: VRA504, 0.8% RESOLVE PANEL B LOT: VRB347. THERE WERE NO NON-CONFORMANCE'S ASSOCIATED WITH THESE LOTS. ANTIGEN SPECIFICITY BY TUBE TEST (FINAL CONTAINER RELEASE STAGE) WAS REVIEWED AND THIS LOT MET ALL ACCEPTANCE CRITERIA. AS PART OF THE INVESTIGATION, A REVIEW OF THE MANUFACTURING BATCH RECORD WAS REQUESTED FOR MTS ANTI-IGG GEL CARD LOT: 110825001-07 AND 110825001-14. RESULT FOR LOT: 110825001-07: THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED AND NO DISCREPANCIES WERE DISCOVERED. ALL IN-PROCESS AND FINAL RELEASE SEROLOGICAL TESTING RESULTS WERE WITHIN SPECIFICATIONS, INCLUDING CUSTOMER USE ORTHO VISION TESTING RESULTS. ALL QC INSPECTION RECORDS (PACKAGING AND GEL CARD INSPECTION DOCUMENTS) OF THIS PRODUCT LOT INDICATED ACCEPTABLE RESULTS; NO GEL CARD DEFECTS WERE IDENTIFIED DURING QC INSPECTION. ALL ID-MTS GEL CARDS USED DURING IN-PROCESS QC TESTING PASSED THE VISUAL CHECK PERFORMED BY THE SEROLOGIST. THE EQUIPMENT AREA USE LOG USED DURING PRODUCTION OF THIS LOT WAS REVIEWED AND NO CONDITIONS OR ACTIONS TAKEN WERE FOUND TO DIRECTLY CONTRIBUTE TO THIS CUSTOMER COMPLAINT. FORMULATION STAGE BATCH RECORD ASSOCIATED WITH THIS ID-MTS GEL CARD LOT WAS REVIEWED AND THERE WAS A NONCONFORMANCE'S RELATED TO THIS LOT. NC0612861 WAS OPENED FOR INCORRECT CONVERSION FACTOR USED IN CALCULATION. BASED ON THE ANALYSIS AND THE RECALCULATION, IT WAS CONCLUDED THAT THERE IS NO IMPACT TO PRODUCT QUALITY OR SPECIFICATION CONFORMANCE FOR THE 198 BOTTLES OF ANTIIGG GEL LOT: 110825001 AND THEY WERE RELEASED FOR USE. RESULT FOR LOT: 110825001-14: THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED AND NO DISCREPANCIES WERE DISCOVERED. ALL IN-PROCESS AND FINAL RELEASE SEROLOGICAL TESTING RESULTS WERE WITHIN SPECIFICATIONS, INCLUDING CUSTOMER USE ORTHO VISION TESTING RESULTS. ALL QC INSPECTION RECORDS (PACKAGING AND GEL CARD INSPECTION DOCUMENTS) OF THIS PRODUCT LOT INDICATED ACCEPTABLE RESULTS; NO GEL CARD DEFECTS WERE IDENTIFIED DURING QC INSPECTION. ALL ID-MTS GEL CARDS USED DURING IN-PROCESS QC TESTING PASSED THE VISUAL CHECK PERFORMED BY THE SEROLOGIST. THE EQUIPMENT AREA USE LOG USED DURING PRODUCTION OF THIS LOT WAS REVIEWED AND NO CONDITIONS OR ACTIONS TAKEN WERE FOUND TO DIRECTLY CONTRIBUTE TO THIS CUSTOMER COMPLAINT. FORMULATION STAGE BATCH RECORD ASSOCIATED WITH THIS ID-MTS GEL CARD LOT WAS REVIEWED AND THERE WAS A NONCONFORMANCE'S RELATED TO THIS LOT. NC0612861 WAS OPENED FOR INCORRECT CONVERSION FACTOR USED IN CALCULATION. BASED ON THE ANALYSIS AND THE RECALCULATION, IT WAS CONCLUDED THAT THERE IS NO IMPACT TO PRODUCT QUALITY OR SPECIFICATION CONFORMANCE FOR THE 198 BOTTLES OF ANTIIGG GEL LOT: 110825001 AND THEY WERE RELEASED FOR USE. BOTH LOTS MET ALL SPECIFICATIONS, ALL IN-PROCESS AND PRODUCT RELEASE CRITERIA. RETAIN SAMPLE OF 0.8% SELECTOGEN LOTS: VS767 AND VS769 WERE TESTED AT ORTHO MANUFACTURING SITE: RETAIN 0.8% SELECTOGEN LOT: VS767 CELLS WERE TESTED IN VISION MTS IAT WITH KNOWN PLASMA: ANTI-D, ANTI-K, ANTI-FYA AND MTS ANTI-IGG LOT: 071025001-12. EXPECTED POSITIVE AND NEGATIVE RESULTS WERE OBTAINED. MTS IGG LOTS: 110825001-07 AND 110825001-14 WERE NOT AVAILABLE. CELL 2 WAS TESTED IN TUBE FOR THE PRESENCE OF THE E ANTIGEN. FIRST THE 0.8% CELL WAS CONVERTED TO A 3% CELL SUSPENSION IN ORS, ORTHO RESUSPENSION SOLUTION, LOT: RS889A, AND THEN TESTED WITH ORTHO REAGENT: ANTI-E BIOCLONE, AS PER IFU, 3% RBC TUBE METHOD. AT IMMEDIATE SPIN, AN EXPECTED POSITIVE REACTION WAS OBSERVED (4+). RESULT MEETS SPECIFICATIONS, A MINIMUM REACTION OF 2+ IS REQUIRED. 0.8% SELECTOGEN LOT: VS767 CONTINUES TO PERFORM AS EXPECTED AND MEETS RELEASE SPECIFICATIONS. RETAIN 0.8% SELECTOGEN LOT: VS769 CELLS WERE TESTED IN VISION MTS IAT WITH KNOWN PLASMA: ANTI-D, ANTI-K, ANTI-FYA AND MTS ANTI-IGG LOT: 071025001-12. EXPECTED POSITIVE AND NEGATIVE RESULTS WERE OBTAINED. MTS IGG LOTS: 110825001-07 AND 110825001-14 WERE NOT AVAILABLE. CELL 2 WAS TESTED IN TUBE FOR THE PRESENCE OF THE E ANTIGEN. FIRST THE 0.8% CELLS WERE CONVERTED TO A 3% CELL SUSPENSION IN ORS, ORTHO RESUSPENSION SOLUTION, LOT: RS889A, AND THEN TESTED WITH ORTHO REAGENT: ANTI-E BIOCLONE, AS PER IFU, 3% RBC TUBE METHOD. AT IMMEDIATE SPIN, EXPECTED POSITIVE REACTIONS WERE OBSERVED (4+). RESULT MEET SPECIFICATIONS, A MINIMUM REACTION OF 2+ IS REQUIRED. 0.8% SELECTOGEN LOT: VS769 CONTINUES TO PERFORM AS EXPECTED AND MEETS RELEASE SPECIFICATIONS. RETAIN SAMPLE OF 0.8% RESOLVE PANEL A LOT: VRA504: RETAIN 0.8% RESOLVE PANEL A LOT: VRA504 CELLS WERE TESTED IN VISION MTS IAT WITH KNOWN PLASMA: ANTI-D, ANTI-K, ANTI-FYA AND MTS ANTI-IGG LOT: 071025001-12. EXPECTED POSITIVE AND NEGATIVE RESULTS WERE OBTAINED. MTS IGG LOTS: 110825001-07 AND 110825001-14 WERE NOT AVAILABLE. CELLS 3 AND 6 WERE TESTED IN TUBE FOR THE PRESENCE OF THE E ANTIGEN. FIRST THE 0.8% CELLS WERE CONVERTED TO A 3% CELL SUSPENSION IN ORS, ORTHO RESUSPENSION SOLUTION, LOT: RS889A, AND THEN TESTED WITH ORTHO REAGENT: ANTI-E BIOCLONE, AS PER IFU, 3% RBC TUBE METHOD. AT IMMEDIATE SPIN, EXPECTED POSITIVE REACTIONS WERE OBSERVED (4+ REACTIONS FOR BOTH CELLS). RESULTS MEET SPECIFICATIONS, A MINIMUM REACTION OF 2+ IS REQUIRED. 0.8% RESOLVE PANEL A LOT: VRA504 CONTINUES TO PERFORM AS EXPECTED AND MEETS RELEASE SPECIFICATIONS. RETAIN SAMPLE OF 0.8% RESOLVE PANEL B LOT: VRB347: RETAIN 0.8% RESOLVE PANEL B LOT: VRB347 CELLS WERE TESTED IN VISION MTS IAT WITH KNOWN PLASMA: ANTI-D, ANTI-K, ANTI-FYA AND MTS ANTI-IGG LOT: 071025001-12. EXPECTED POSITIVE AND NEGATIVE RESULTS WERE OBTAINED. MTS IGG LOTS: 110825001-07 AND 110825001-14 WERE NOT AVAILABLE. CELLS 15,16,17 AND 20 WERE TESTED IN TUBE FOR THE PRESENCE OF THE E ANTIGEN. FIRST THE 0.8% CELLS WERE CONVERTED TO A 3% CELL SUSPENSION IN ORS, ORTHO RESUSPENSION SOLUTION, LOT: RS889A, AND THEN TESTED WITH ORTHO REAGENT: ANTI-E BIOCLONE, AS PER IFU, 3% RBC TUBE METHOD. AT IMMEDIATE SPIN, EXPECTED POSITIVE REACTIONS WERE OBSERVED (4+ FOR ALL 4 CELLS). RESULTS MEET SPECIFICATIONS, AS PER QAT50016, A MINIMUM REACTION OF 2+ IS REQUIRED. 0.8% RESOLVE PANEL B LOT: VRB347 CONTINUES TO PERFORM AS EXPECTED AND MEETS RELEASE SPECIFICATIONS. A REVIEW OF THE HISTORY OF THE DONORS USED TO MANUFACTURE CELLS 2 OF 0.8% SELECTOGEN LOT: VS767 AND VS769, CELL 6 OF 0.8% RESOLVE PANEL A LOT: VRA507 AND CELLS 16 AND 17 OF 0.8% RESOLVE PANEL B LOT: VRB347 BEING E(RH3) ANTIGEN POSITIVE WAS PERFORMED. NO TREND OR SYSTEMATIC FAILURE OF THESE DONORS WAS IDENTIFIED. RETAIN TESTING OF MTS ANTI-IGG CARD LOTS: 110825001-07 / 110825001-14 WAS REQUESTED TO BE PERFORMED. ANTI-IGG CARD LOT#: 110825001-07 AND 110825001-14 RETENTION CARDS WERE TESTED ON THE ORTHO VISION ANALYZER WITH 0.8% SELECTOGEN LOT#: VS770 AND ORTHO DAILY QC KIT LOT#: EB031 CONTAINING ANTI-D, ANTI-C AND ANTI-FYA (ANTI-K NOT AVAILABLE). A TOTAL OF 100 RETENTION CARDS OF ANTI-IGG CARD LOT#: 110825001-07 AND 110825001-14 WERE VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. ALL RESULTS WERE AS EXPECTED AND NO DISCREPANT RESULTS WERE OBTAINED. CUSTOMER COMPLAINT WAS NOT CONFIRMED. A COMPLAINT REVIEW WAS PERFORMED THROUGH 24MAR2026 FOR 0.8% SELECTOGEN LOT: VS767 AND VS769, 0.8% RESOLVE PANEL A LOT: VRA504 AND 0.8% RESOLVE PANEL B LOT: VRB347. NO OTHER COMPLAINT WAS IDENTIFIED FOR FALSE NEGATIVE RESULTS WITH THESE LOTS. NO TREND WAS IDENTIFIED FOR THESE LOTS. A COMPLAINT REVIEW OF MTS ANTI-IGG GEL CARD LOTS: 110825001-07 AND 110825001-14 WAS ALSO PERFORMED THROUGH 24MAR2026. NO COMPLAINTS WERE IDENTIFIED AGAINST THE CARD LOTS FOR FALSE NEGATIVE REACTIONS IN ANTIBODY SCREENING. FOR THOROUGHNESS, THE MOTHER BULK LOT: 110825001, WAS ALSO REVIEWED. TWO COMPLAINTS FROM ONE CUSTOMER WITH LOT: 110825001-10 FOR FALSE NEGATIVE CALL AREA WERE IDENTIFIED. DETAILED REVIEW OF THE ACTIVITIES OF THESE TWO COMPLAINTS FAILED TO IDENTIFY A SIMILAR COMPLAINT AS REPORTED BY THE CUSTOMER. NO TREND FOR FALSE NEGATIVE CALL AREA WERE FOUND FOR THE SUBLOT OR MOTHER BULK. NO FURTHER INVESTIGATION WAS PERFORMED ON THESE INCIDENTS. THE POTENTIAL ASSIGNABLE CAUSE IS LIKELY SAMPLE RELATED, THE PATIENT'S ANTI-E ANTIBODY BEING WEAK AND/OR AT THE DETECTION LIMIT OF THE TECHNIQUE AND REAGENTS USED AND/OR ASSOCIATED TO THE VARIABILITY OF THE E(RH3) ANTIGEN EXPRESSION ON THE REAGENT RED BLOOD CELLS. THERE IS NO EVIDENCE OF ANY SYSTEMATIC FAILURE OF THE ORTHO CLINICAL DIAGNOSTICS REAGENTS OR ANALYZERS TO PERFORM AS INTENDED. IN MITIGATION OF THE DISCORDANT NEGATIVE ANTIBODY SCREEN/IDENTIFICATION RESULTS, THE 0.8% SELECTOGEN, 0.8% RESOLVE PANEL A AND 0.8% RESOLVE PANEL B INSTRUCTIONS FOR USE STATE: FOR ANTIBODY DETECTION AND IDENTIFICATION, DIFFERENT SEROLOGICAL METHODS ARE OPTIMAL FOR DIFFERENT ANTIBODIES. NO SINGLE ANTIBODY SCREENING OR IDENTIFICATION METHOD OPTIMALLY DETECTS ALL ANTIBODIES. IN SOME LOW IONIC STRENGTH TEST SYSTEMS, CERTAIN ANTI-E AND ANTI-K ANTIBODIES HAVE BEEN REPORTED TO BE NONREACTIVE. NO FURTHER COMPLAINT OF THIS TYPE HAS BEEN RECEIVED FROM THE CUSTOMER SITE SINCE THE TIME OF THE REPORTED EVENTS.
CMS 100847098 / RA613978 ON (B)(6) 2026, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS FALSE NEGATIVE ANTIBODY SCREEN/IDENTIFICATION RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT ON THEIR ORTHO VISION SWIFT ID-MTS ANALYZERS (50003311 AND 50003312) USING 0.8% SELECTOGEN LOTS: VS767 / VS769, 0.8% RESOLVE PANEL A LOT: VRA504 AND 0.8% RESOLVE PANEL B VRB347 IN CONJUNCTION WITH MTS ANTI-IGG GEL CARD LOTS: 110825001-07 / 110825001-14. COMPLAINANT: (B)(6) CUSTOMER (B)(6); (B)(6) DATES OF EVENTS: 04 AND 13MAR2026; REPORTED 16MAR2026 EQUIPMENT: ORTHO VISION ID-MTS ANALYZER SERIAL NUMBERS: (B)(6) REAGENTS: 0.8% SELECTOGEN LOT: VS767, EXPIRY 17MAR2026, MANUFACTURED 13JAN2026 0.8% SELECTOGEN LOT: VS769, EXPIRY 31MAR2026, MANUFACTURED 27JAN2026 0.8% RESOLVE PANEL A LOT: VRA504, EXPIRY 17MAR2026, MANUFACTURED 13JAN2026 0.8% RESOLVE PANEL B LOT: VRB347, EXPIRY 17MAR2026, MANUFACTURED 13JAN2026 MTS ANTI-IGG GEL CARD LOT: 110825001-07, EXPIRY 24AUG2026, MANUFACTURED 24NOV2025 MTS ANTI-IGG GEL CARD LOT: 110825001-14, EXPIRY 10SEP2026, MANUFACTURED 10DEC2025 PATIENT INFORMATION: SAMPLE IDS: (B)(6) (SAMPLE 1) AND (B)(6) (SAMPLE 2) PATIENT SAMPLE 1 WAS COLLECTED ON (B)(6) 2026 IN A (B)(6) HOSPITAL. THE PATIENT WAS DISCHARGED FROM THE (B)(6) HOSPITAL AND SENT TO OUR CURRENT CUSTOMER ON (B)(6) 2026 WHERE FOLLOWING TESTING WAS PERFORMED. PATIENT SAMPLE 2 WAS COLLECTED BY THE CURRENT CUSTOMER ON (B)(6) 2026. THE CUSTOMER REPORTED THAT ON (B)(6) 2026, PATIENT SAMPLE 1 WAS TESTED FOR ANTIBODY SCREENING USING 0.8% SELECTOGEN LOT: VS767 AND MTS ANTI-IGG GEL CARD LOT: 110825001-07 IN CONJUNCTION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZER (50003312) AND THEY OBTAINED NEGATIVE REACTIONS WITH BOTH CELLS OF THE RED CELL REAGENT. THE CUSTOMER REPORTED THAT A NEGATIVE RESULT FOR THIS PATIENT WAS PROVIDED TO THE PHYSICIAN AND THAT THE PATIENT WAS TRANSFUSED THAT DAY WITH ONE BLOOD UNIT POSITIVE FOR E (RH3) ANTIGEN. THE CUSTOMER SAID THAT THERE WAS NO REPORT OF ANY TRANSFUSION REACTION SIGNS FOR THE PATIENT DURING/AFTER THE TRANSFUSION. THE CUSTOMER REPORTED THAT THEY WERE NOTIFIED ON THE (B)(6) 2026 BY THE FIRST HOSPITAL THAT THIS PATIENT WAS FOUND TO HAVE AN ANTI-E (RH3) ANTIBODY ON (B)(6) 20026 WITH THE FOLLOWING TECHNIQUES: ANTIBODY SCREENING PERFORMED IN SOLID PHASE WITH A COMPETITOR'S REAGENT: NEGATIVE/1+/NEGATIVE -ANTIBODY IDENTIFICATION PERFORMED IN SOLID PHASE WITH A COMPETITOR'S REAGENT: E (RH3) POSITIVE CELLS GAVE "?" INDETERMINATE REACTIONS -ANTIBODY IDENTIFICATION IN ENZYME TECHNIQUE IN GEL METHOD WITH A COMPETITOR'S REAGENT: E(RH3) POSITIVE CELLS GAVE 3+ REACTIONS. NO FURTHER DETAILS WERE PROVIDED. THESE RESULTS WERE NOT COMMUNICATED TO OUR CUSTOMER ON (B)(6) 2026. THE CUSTOMER REPORTED THAT A SECOND SAMPLE (SAMPLE 2) WAS DRAWN FROM THE PATIENT ON (B)(6) 2026. THE CUSTOMER REPORTED THAT ON (B)(6) 2026, PATIENT SAMPLE 2 WAS TESTED FOR ANTIBODY SCREENING USING 0.8% SELECTOGEN LOT: VS769 AND MTS ANTI-IGG GEL CARD LOT: 110825001-14 IN CONJUNCTION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZER (50003312) AND OBTAINED NEGATIVE REACTIONS WITH BOTH CELLS OF THE RED CELL REAGENT. THE CUSTOMER REPORTED THAT ON THE SAME DAY, PATIENT SAMPLE 2 WAS TESTED FOR ANTIBODY SCREENING USING 0.8% SELECTOGEN LOT VS767 AND MTS ANTI-IGG GEL CARD LOT: 110825001-14 IN CONJUNCTION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZER (50003311) AND OBTAINED NEGATIVE REACTIONS WITH BOTH CELLS OF THE RED CELL REAGENT. THE CUSTOMER REPORTED THAT ON (B)(6) 2026, PATIENT SAMPLE 2 WAS TESTED FOR ANTIBODY IDENTIFICATION USING 0.8% RESOLVE PANEL A LOT: VRA504 IN IAT (SELECTED CELLS 1, 3 AND 6) AND MTS ANTI-IGG GEL CARD LOT: 110825001-14 IN CONJUNCTION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZER (50003311) AND OBTAINED NEGATIVE REACTIONS WITH THE THREE CELLS. THE CUSTOMER REPORTED THAT ON (B)(6) 2026, PATIENT SAMPLE 2 WAS TESTED FOR ANTIBODY IDENTIFICATION USING 0.8% RESOLVE PANEL B LOT: VRB347 IN IAT (SELECTED CELLS 13, 15, 16, 17 AND 20) AND MTS ANTI-IGG GEL CARD LOT: 110825001-14 IN CONJUNCTION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZER (50003311) AND OBTAINED: -CELLS 13, 16, 17 AND 20: NEGATIVE REACTIONS. -CELL 15: 1+ REACTION. THE CUSTOMER REPORTED THAT ON THE SAME DAY, PATIENT SAMPLE 1 WAS TESTED FOR ANTIBODY IDENTIFICATION USING 0.8% RESOLVE PANEL A LOT: VRA504 IN IAT (SELECTED CELLS 1, 3 AND 6) AND MTS ANTIIGG GEL CARD LOT: 110825001-14 IN CONJUNCTION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZER (50003311) AND OBTAINED: -CELLS 1 AND 6: NEGATIVE REACTIONS. -CELL 3: 1+ REACTION. THE CUSTOMER REPORTED THAT ON (B)(6) 2026, PATIENT SAMPLE 1 WAS TESTED FOR ANTIBODY IDENTIFICATION USING 0.8% RESOLVE PANEL B LOT: VRB347 IN IAT (SELECTED CELLS 13, 15, 16, 17 AND 20) AND MTS ANTI-IGG GEL CARD LOT: 110825001-14 IN CONJUNCTION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZER (50003311) AND OBTAINED: -CELLS 13, 16 AND 17: NEGATIVE REACTIONS. -CELLS 15 AND 20: 1+ REACTION. THE CUSTOMER REPORTED THAT THE PATIENT WAS TRANSFUSED ON (B)(6) 2026 WITH ONE BLOOD UNIT NEGATIVE FOR E (RH3) ANTIGEN. THE CUSTOMER MENTIONED A FEBRILE TRANSFUSION REACTION THAT WAS NOT LINKED TO AN INTERACTION ANTIBODY/ANTIGEN AND NOT LINKED TO ANY RESULTS PROVIDED BY ORTHO DEVICES. A BIASED RESULT WAS REPORTED ON (B)(6) 2026 TO THE PHYSICIAN. THE PATIENT WAS NOT HARMED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 910427 | 0.8% RESOLVE B 11X3ML | REAGENT RED BLOOD CELLS | QHT | ORTHO-CLINICAL DIAGNOSTICS, INC. | VRB347 | 10758750007684 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |