ALINITY I TOTAL PSA REAGENT KIT
Report
- Report Number
- 3008344661-2025-00158
- Event Type
- Malfunction
- Date Received
- November 17, 2025
- Date of Event
- November 3, 2025
- Report Date
- February 9, 2026
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- MTF
- UDI-DI
- 00380740130442
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
SECTION A1 - PATIENT IDENTIFIER: SAMPLE IDS = (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P92-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P92-21 / 31, WITH 510K/PMA/BLA NUMBER P910007. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
SECTION A2 - AGE AT TIME OF EVENT, A2 - AGE UNITS (PATIENT), AND A3A - SEX WAS UPDATED FROM BLANK TO 58-YEAR-OLD MALE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P92-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P92-21 / 31, WITH 510K/PMA/BLA NUMBER P910007. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
SECTION B5 - DESCRIBE EVENT OR PROBLEM: THIS SECTION WAS UPDATED WITH ADDITIONAL INFORMATION PROVIDED ON 28JAN2026. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORTED THE COMPLAINT ISSUE WITHOUT INDICATION OF ANY ADDITIONAL ISSUES. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 77236FZ00. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I TOTAL PSA ASSAY DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS WITH LOT NUMBER 77236FZ00 AND THE COMPLAINT ISSUE. PERFORMANCE TESTING WAS COMPLETED USING AN IN-HOUSE RETAIN KIT OF THE COMPLAINT LOT. ALL SPECIFICATIONS WERE MET, INDICATING THE LOT IS PERFORMING ACCEPTABLY. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER¿S ISSUE. WITH REGARD TO THE BECKMAN RESULT, THE PACKAGE INSERT STATES; ¿THE CONCENTRATION OF TOTAL PSA IN A GIVEN SPECIMEN, DETERMINED WITH ASSAYS FROM DIFFERENT MANUFACTURERS, CAN VARY DUE TO DIFFERENCES IN ASSAY METHODS AND REAGENT SPECIFICITY. THE RESULTS REPORTED BY THE LABORATORY TO THE PHYSICIAN MUST INCLUDE THE IDENTITY OF THE TOTAL PSA ASSAY USED. VALUES OBTAINED WITH DIFFERENT ASSAY METHODS CANNOT BE USED INTERCHANGEABLY¿. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I TOTAL PSA REAGENT, LOT NUMBER 77236FZ00.
THE CUSTOMER REPORTED IMPRECISE ALINITY I TOTAL PSA RESULTS GENERATED BY THE ALINITY I PROCESSING MODULES FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL RANGE: 0 TO 4 NG/ML. SID (B)(6) (FIRST BLOOD DRAW): ON (B)(6) 2025 INITIAL RESULT (AI23680) = 6.78 NG/ML (LOT 77485FZ00), ON (B)(6) 2025 REPEATED ON ANALYZER AI23691 = 3.56 NG/ML (LOT 77236FZ00), ON (B)(6) 2025 REPEATED ON ANALYZER AI23691 = 3.58, 3.55, 3.56, 3.59, 3.28, 3.55, 3.38, 3.53, 3.69, 3.45, 3.69 NG/ML (LOT 77236FZ00), ON (B)(6) 2025 REPEATED ON ANALYZER AI23680 = 7.00, 6.96, 7.07, 6.84, 6.53, 6.87, 7.24, 6.80, 6.82, 6.70, 6.38 NG/ML (LOT 77485FZ00), ON (B)(6) 2025 REPEATED ON ANALYZER AI23681 = 3.62 NG/ML (LOT 77236FZ00), 6.5 NG/ML (LOT 77485FZ00). SID (B)(6), (SECOND BLOOD DRAW): INITIAL RESULT = 6.06 NG/ML (LOT 77236FZ00), REPEAT RESULT = 3.35 NG/ML (LOT 77485FZ00), ON (B)(6) 2025 REPEAT RESULTS = 6.07 NG/ML AND 6.21 NG/ML (LOT 79074FZ00), BECKMAN RESULT (FROM ANOTHER LAB) = 2.99 NG/ML. THE CUSTOMER DOES NOT KNOW WHICH RESULT IS CORRECT FOR THIS PATIENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER REPORTED IMPRECISE ALINITY I TOTAL PSA RESULTS GENERATED BY THE ALINITY I PROCESSING MODULES FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL RANGE: 0 TO 4 NG/ML. SID (B)(6) (FIRST BLOOD DRAW): (B)(6) 2025 INITIAL RESULT (B)(6) = 6.78 NG/ML (LOT 77485FZ00). (B)(6) 2025 REPEATED ON ANALYZER (B)(6) = 3.56 NG/ML (LOT 77236FZ00). (B)(6) 2025 REPEATED ON ANALYZER (B)(6) = 3.58, 3.55, 3.56, 3.59, 3.28, 3.55, 3.38, 3.53, 3.69, 3.45, 3.69 NG/ML (LOT 77236FZ00). (B)(6) 2025 REPEATED ON ANALYZER (B)(6) = 7.00, 6.96, 7.07, 6.84, 6.53, 6.87, 7.24, 6.80, 6.82, 6.70, 6.38 NG/ML (LOT 77485FZ00). (B)(6) 2025 REPEATED ON ANALYZER (B)(6) = 3.62 NG/ML (LOT 77236FZ00), 6.5 NG/ML (LOT 77485FZ00). SID (B)(6) (SECOND BLOOD DRAW): INITIAL RESULT = 6.06 NG/ML (LOT 77236FZ00), REPEAT RESULT = 3.35 NG/ML (LOT 77485FZ00) (B)(6) 2025 REPEAT RESULTS = 6.07 NG/ML AND 6.21 NG/ML (LOT 79074FZ00) BECKMAN RESULT (FROM ANOTHER LAB) = 2.99 NG/ML THE CUSTOMER DOES NOT KNOW WHICH RESULT IS CORRECT FOR THIS PATIENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. UPDATE: ON (B)(6) 2026, THE CUSTOMER PROVIDED A CORRECTION TO THE DATA FOR THE SECOND BLOOD DRAW (SID (B)(6)). THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) (SECOND BLOOD DRAW): (B)(6) 2025 INITIAL RESULT (B)(6) = 6.06 NG/ML (LOT 77485FZ00), REPEAT RESULT (B)(6) = 3.35 NG/ML (LOT 77236FZ00). (B)(6) 2025 REPEAT RESULTS ON ANALYZER (B)(6) = 6.07 NG/ML AND 6.21 NG/ML (LOT 79074FZ00). (B)(6) 2025 REPEAT RESULT ON (B)(6) = 3.31 NG/ML (77236FZ00). BECKMAN RESULT (FROM ANOTHER LAB) = 2.99 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 274485 | ALINITY I TOTAL PSA REAGENT KIT | TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER | MTF | ABBOTT IRELAND DIAGNOSTICS DIVISION | 77236FZ00 | 00380740130442 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Male | ALNTY I PROCESSING MODU, 03R65-01, (B)(6),| ALNTY I PROCESSING MODU, 03R65-01, (B)(6),| ALNTY I PROCESSING MODU, 03R65-01, (B)(6). |