BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
Report
- Report Number
- 1119779-2021-00038
- Event Type
- Malfunction
- Date Received
- January 7, 2021
- Date of Event
- December 14, 2020
- Report Date
- November 18, 2021
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- QKP
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6: INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT RAPID DETECTION OF SARS-COV-2 VERITOR (MATERIAL # 256082), BATCH NUMBER: 0289298. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. A BATCH REVIEW WAS PERFORMED FOR THE NUMBER PROVIDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THE RETENTION TESTING COULD NOT BE TESTED AS THEY ARE EXPIRED. RETURNED PRODUCT TESTING COULD NOT BE COMPLETED A SAMPLES ARE EXPIRED. THERE ARE NO CURRENT TRENDS AGAINST FALSE POSITIVE RESULTS. BD HAS INITIATED CAPA #1878253 TO FURTHER INVESTIGATE. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS.
IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE THREE (3) POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING THE ABBOTT ID TEST METHOD AND THE RESULTS WERE NEGATIVE. THE CUSTOMER STATED THE PATIENTS TESTED WERE ASYMPTOMATIC. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT OR ANY REPORT OF PATIENT IMPACT. EUA (B)(4). (B)(6): (B)(6) 2021 14:07:45 (GMT). SUBJECT: CALL (B)(6) 2021, 9:01:24 AM. USER: (B)(6). CREATED ON: (B)(6) 2021 14:01:24. CALL ACTIVITY COMMENT: FOLLOWED UP WITH CUSTOMER. CUSTOMER CONFIRMED REPLACEMENT KIT WAS RECEIVED. ALSO, CUSTOMER STATED A 2ND ANALYZER WAS RECEIVED. ADVISED CUSTOMER TO KEEP 2ND UNIT AS BD CAN'T RE STOCK IT. (B)(6): (B)(6) 2021 22:09:49 (GMT). FOLLOW UP EMAIL SENT TO CUSTOMER REGARDING REPLACEMENT KIT RECEIPT. TM. (B)(6): (B)(6) 2020 15:45:16 (GMT). SUBJECT: CALL (B)(6) 2020, 10:28:39 AM. USER: (B)(6). CREATED ON: (B)(6) 2020 15:28:39. CALL ACTIVITY COMMENT: FOLLOWED UP WITH CUSTOMER. CUSTOMER CONFIRMED NEW ANALYZER WAS RECEIVED. CUSTOMER STILL WAITING ON KIT REPLACEMENT. ADVISED CUSTOMER THAT PRODUCT HAS NOT BEEN SHIPPED YET. (B)(6): (B)(6) 2020 13:46:19 (GMT). RETURN RECEIVED (ANALYZER) ON (B)(6) 2020 AT 11:16AM. RETURN RECEIVED (KIT) ON (B)(6) 2020 AT 3:46PM. (B)(6): (B)(6) 2020 19:16:06 (GMT). REVIEWED, PENDING FOLLOW UP. (B)(6): (B)(6) 2020 13:42:42 (GMT): FREE OF CHARGE ORDER (B)(4). MATERIAL NO. 256082. LOT NO. 0289298. IT WAS REPORTED THAT 4 FALSE POSTIVES. (B)(6): (B)(6) 2020 03:36:55 (GMT). PLEASE SHIP FOC-QUALITY. APPROVED BY C. POFF. 1X- 256066 - BD VERITOR PLUS ANALYZER. 2X- 256082 - RAPID DETECTION OF SARS-COV-2 VERITOR. ATTN: (B)(6) / (B)(6). (B)(6): (B)(6) 2020 03:33:59 (GMT). PROCESSING QUESTIONS: HOW LONG AFTER SPECIMEN COLLECTION WAS THE SPECIMEN PROCESSED IN THE EXTRACTION REAGENT? IMMEDIATELY. HOW WAS THE SPECIMEN STORED BETWEEN COLLECTION AND PROCESSING IN THE EXTRACTION REAGENT? N/A. HOW LONG AFTER PROCESSING IN THE EXTRACTION REAGENT WAS THE SPECIMEN RUN ON THE TEST CARTRIDGE? IMMEDIATELY. HOW MANY DROPS WERE ADDED TO THE SAMPLE WELL ON THE TEST DEVICE? WAS WALK-AWAY MODE USED OR ANALYZE NOW MODE? 3 DROPS, ANALYZE NOW MODE. WERE THE KIT QC SWABS TESTED AND IF SO, DID THEY PASS? QC DONE WHEN NEW BOX IS OPENED. INCUBATION TIME: HOW LONG WAS SAMPLE RUN ON THE CARTRIDGE BEFORE READING? 15 MINUTES TEMPERATURE: CLARIFY THE ENVIRONMENT TEMPERATURE AND TIME AT TEMP SET TEMP FOR THE ENTIRE LAB. FACILITY IS TEMP CONTROLLED BETWEEN 72-74F. WAS TESTING PERFORMED INDOORS OR OUTDOORS (NOT COLLECTION). INDOOR. COULD YOU PLEASE PROVIDE A PHOTO OF THE KIT LABEL? IF AVAILABLE, COULD YOU PROVIDE A PHOTO OF THE CARTRIDGE? CARTRIDGE NO LONGER AVAILABLE. (B)(6). (B)(6) 2020 03:33:49 (GMT). WAS THE CARTRIDGE RERUN (RE-READ)? IF SO, HOW LONG AFTER THE INITIAL RUN WAS THE CARTRIDGE RERUN (RE-READ)? NO. WAS THE CARTRIDGE VISUALLY READ? NO. HOW MANY SPECIMENS WERE DISCREPANT (FP OR FN)? 4 FP. COULD YOU PROVIDE THE SPECIMEN IDENTIFIER FOR EACH RESULT IN QUESTION? COULD YOU PROVIDE THE DATE/TIME EACH AFFECTED SPECIMEN WAS INITIALLY TESTED? (B)(6) 2020. ON AVERAGE HOW MANY TESTS DO YOU RUN PER WEEK? DOES NOT KNOW. WERE ANY ERRONEOUS RESULTS REPORTED TO THE DOCTORS? NOT REPORTED TO DOCTOR. WAS THERE ANY PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? IF SO, DID THE ERRONEOUS TREATMENT HAVE ANY ADVERSE IMPACT TO THE PATIENT(S)? NONE HAS NEEDED TREATMENT. STAFF MEMBERS WERE NOT SENT HOME. CAN YOU PLEASE CLARIFY THE TOTAL NUMBER OF KIT BOXES RECEIVED AND TOTAL NUMBER AFFECTED? CUSTOMER DOES NOT KNOW QUANTITY RECEIVED. PER CUSTOMER, 1 BOX AFFECTED SO FAR. (B)(6): (B)(6) 2020 03:33:14 (GMT). PLEASE PROVIDE THE SERIAL NUMBER FOR THE ANALYZER. PLEASE PROVIDE PHOTO IF AVAILABLE 2008070J4B5A0. PLEASE PROVIDE THE KIT LOT NUMBER (SHOULD BE ON SIDE OF THE BOX). PLEASE PROVIDE PHOTO IF AVAILABLE. WOULD YOU BE WILLING TO RETURN 1 KIT BOX? I COULD SEND A REPLACEMENT. LOT 0289298. CUSTOMER WILL SEND RETURN. HOW WAS THE SPECIMEN COLLECTED? DID IT FOLLOW THE DUAL-NARES COLLECTION METHOD DESCRIBED IN THE PRODUCT INSERT? YES, BOTH NARES. WHAT TYPE OF SWAB WAS USED TO COLLECT THE SPECIMEN? WAS THE ONE INCLUDED IN THE KIT? SWAB PROVIDED WITH KIT. WAS ANY TRANSPORT MEDIA USED? (THIS WOULD BE OUTSIDE PI CLAIMS) NO. WHAT DATE WAS THE SPECIMEN COLLECTED? 4 SPECIMENS ON (B)(6) 2020. WHAT DATE WAS THE SPECIMEN RUN? SAME DAY OF COLLECTION. WAS PATIENT SYMPTOMATIC OR ASYMPTOMATIC? 3 WERE ASYMPTOMATIC. 1 HAS BRONCHITIS THAT HAS BEEN TESTED MULTIPLE TIMES AND RESULTS WERE NEGATIVE. SCREENING TEST: NO KNOWN EXPOSURE? TESTING WAS ROUTINE TESTING SCREENING. SCREENING TEST: KNOWN EXPOSURE THAT IS CURRENTLY ASYMPTOMATIC? N/A. ASYMPTOMATIC BUT DR RECOMMENDED TESTING? N/A. HOW WAS IT DETERMINED TO BE DISCREPANT? CUSTOMER USED THEIR OTHER TEST METHOD, ABBOTT IDNOW. COMPARISON TO ANOTHER METHOD? YES. CUSTOMER SENT SWAB FOR PCR TESTING FOR SYMPTOMATIC STAFF MEMBER ON (B)(6) 2020. PROVIDE DETAIL: REPEATED SAMPLE? (SEE BELOW) USED ABBOTT IDNOW. HOW DID THEY COMPLETE THE REPEAT TEST? 2ND SWAB WAS COLLECTED AND TESTED DIFFERENT METHOD. WAS AN ADDITIONAL SWAB COLLECTED? YES. DID THEY PROCESS THE SAME SWAB IN A 2ND REAGENT TUBE? DID THEY USE THE LEFTOVER EXTRACTION REAGENT FROM THE REAGENT TUBE ON A NEW CARTRIDGE? N/A. (B)(6): (B)(6) 2020 03:28:43 (GMT). CUSTOMER PROBLEM: CUSTOMER REPORTS FOUR FALSE POSITIVE RESULTS WHILE USING CAT 256082 LOT 0289298. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER STATES THE GOT FOUR POSITIVE RESULTS USING THE VERITOR. CUSTOMER STATES THEY HAD PREVIOUSLY REPORTED THE SAME ISSUE WITH OTHER SPECIMENS. SEE CASE (B)(4). PER CUSTOMER, SPECIMENS WERE RECOLLECTED AND REPEATED ABBOTT ID NOW AND RESULTS WERE NEGATIVE. CUSTOMER PROVIDED ANSWERS TO QUESTIONNAIRE. CUSTOMER STATES THEY NEVER RECEIVED THE REPLACEMENT ANALYZER AND KIT FROM THE PREVIOUS CASE. C. POFF AUTHORIZED ANALYZER AND KIT REPLACEMENTS. NEXT STEPS (IF NECESSARY): DOCUMENT COMPLAINT. REQUEST FOC AND RETURNS RESOLUTION ACHIEVED (Y/N)?: N. QUANTITY RECEIVED AND QUANTITY AFFECTED: UNKNOWN QUANTITY RECEIVED, 4 SPECIMENS AFFECTED. SHIPMENT METHOD (DIRECTLY OR VIA DISTRIBUTOR): DISTRIBUTOR. IF IT IS A DISTRIBUTOR ¿ WHO IS IT? MCKESSON. PHOTOS OR RETURNS REQUESTED? REQUESTED RETURNS. TRACKING # ANALYZER (B)(4). TRACKING # ANALYZER (B)(4). REPLACEMENTS OR CREDIT REQUESTED: REPLACEMENTS. FOLLOW UP REQUIRED (Y/N)? Y. IF CONSUMABLE IS TESTED ON BD INSTRUMENTATION, LIST SERIAL NUMBERS: FOLLOW UP EMAIL SENT TO CUSTOMER. TIME STAMP (IF APPLICABLE): N/A. INDICATION THAT CUSTOMER IS INDUSTRIAL INDU (IF APPLICABLE): N/A. IS A LETTER SIGNED BY QUALITY REQUIRED (Y/N)? : Y, SEE 1141010. REVIEWED SMAX CASE HISTORY: Y. HELP LIGHTNING ATTEMPT: N. HELP LIGHTNING SUCCESS: N. (B)(6): (B)(6) 2020 18:54:05 (GMT). SUBJECT: CALL (B)(6) 2020, 1:15:04 PM. USER: (B)(6). CREATED ON: (B)(6) 2020 18:15:05. CALL ACTIVITY COMMENT: CUSTOMER REPORTS FOUR FALSE POSITIVE RESULTS WHILE USING CAT 256082 LOT 0289298. (B)(6): (B)(6) 2020 18:19:29 (GMT). CUSTOMER REPORTS FOUR FALSE POSITIVE RESULTS WHILE USING CAT 256082.
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE THREE (3) POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING THE ABBOTT ID TEST METHOD AND THE RESULTS WERE NEGATIVE. THE CUSTOMER STATED THE PATIENTS TESTED WERE ASYMPTOMATIC. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT OR ANY REPORT OF PATIENT IMPACT. (B)(4). CALL ACTIVITY COMMENT: FOLLOWED UP WITH CUSTOMER. CUSTOMER CONFIRMED REPLACEMENT KIT WAS RECEIVED. ALSO, CUSTOMER STATED A 2ND ANALYZER WAS RECEIVED. ADVISED CUSTOMER TO KEEP 2ND UNIT AS BD CAN'T RE STOCK IT. (B)(4). FOLLOW UP EMAIL SENT TO CUSTOMER REGARDING REPLACEMENT KIT RECEIPT. (B)(4). CALL ACTIVITY COMMENT: FOLLOWED UP WITH CUSTOMER. CUSTOMER CONFIRMED NEW ANALYZER WAS RECEIVED. CUSTOMER STILL WAITING ON KIT REPLACEMENT. ADVISED CUSTOMER THAT PRODUCT HAS NOT BEEN SHIPPED YET. (B)(4). RETURN RECEIVED (ANALYZER) ON 12/22/2020 AT 11:16AM. RETURN RECEIVED (KIT) ON 12/22/2020 AT 3:46PM. (B)(4). REVIEWED, PENDING FOLLOW UP. (B)(4). MATERIAL NO. 256082. LOT NO. 0289298. IT WAS REPORTED THAT 4 FALSE POSTIVES. (B)(4). PLEASE SHIP FOC-QUALITY, APPROVED BY (B)(4). 1X- 256066 - BD VERITOR PLUS ANALYZER. 2X- 256082 - RAPID DETECTION OF SARS-COV-2 VERITOR. (B)(4). PROCESSING QUESTIONS: HOW LONG AFTER SPECIMEN COLLECTION WAS THE SPECIMEN PROCESSED IN THE EXTRACTION REAGENT? IMMEDIATELY. HOW WAS THE SPECIMEN STORED BETWEEN COLLECTION AND PROCESSING IN THE EXTRACTION REAGENT? N/A.HOW LONG AFTER PROCESSING IN THE EXTRACTION REAGENT WAS THE SPECIMEN RUN ON THE TEST CARTRIDGE? IMMEDIATELY. HOW MANY DROPS WERE ADDED TO THE SAMPLE WELL ON THE TEST DEVICE? WAS WALK-AWAY MODE USED OR ANALYZE NOW MODE? 3 DROPS, ANALYZE NOW MODE. WERE THE KIT QC SWABS TESTED AND IF SO, DID THEY PASS? QC DONE WHEN NEW BOX IS OPENED. INCUBATION TIME: HOW LONG WAS SAMPLE RUN ON THE CARTRIDGE BEFORE READING? 15 MINUTES. TEMPERATURE: CLARIFY THE ENVIRONMENT TEMPERATURE AND TIME AT TEMP SET TEMP FOR THE ENTIRE LAB. FACILITY IS TEMP CONTROLLED BETWEEN 72-74F. WAS TESTING PERFORMED INDOORS OR OUTDOORS (NOT COLLECTION). INDOOR. COULD YOU PLEASE PROVIDE A PHOTO OF THE KIT LABEL? IF AVAILABLE, COULD YOU PROVIDE A PHOTO OF THE CARTRIDGE? CARTRIDGE NO LONGER AVAILABLE. (B)(4).WAS THE CARTRIDGE RERUN (RE-READ)? IF SO, HOW LONG AFTER THE INITIAL RUN WAS THE CARTRIDGE RERUN (RE-READ)? NO. WAS THE CARTRIDGE VISUALLY READ? NO. HOW MANY SPECIMENS WERE DISCREPANT (FP OR FN)? 4 FP. COULD YOU PROVIDE THE SPECIMEN IDENTIFIER FOR EACH RESULT IN QUESTION? COULD YOU PROVIDE THE DATE/TIME EACH AFFECTED SPECIMEN WAS INITIALLY TESTED? (B)(6) 2020. ON AVERAGE HOW MANY TESTS DO YOU RUN PER WEEK? DOES NOT KNOW. WERE ANY ERRONEOUS RESULTS REPORTED TO THE DOCTORS? NOT REPORTED TO DOCTOR. WAS THERE ANY PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? IF SO, DID THE ERRONEOUS TREATMENT HAVE ANY ADVERSE IMPACT TO THE PATIENT(S)? NONE HAS NEEDED TREATMENT. STAFF MEMBERS WERE NOT SENT HOME. CAN YOU PLEASE CLARIFY THE TOTAL NUMBER OF KIT BOXES RECEIVED AND TOTAL NUMBER AFFECTED? CUSTOMER DOES NOT KNOW QUANTITY RECEIVED. PER CUSTOMER, 1 BOX AFFECTED SO FAR. (B)(4). PLEASE PROVIDE THE SERIAL NUMBER FOR THE ANALYZER. PLEASE PROVIDE PHOTO IF AVAILABLE (B)(4). PLEASE PROVIDE THE KIT LOT NUMBER (SHOULD BE ON SIDE OF THE BOX). PLEASE PROVIDE PHOTO IF AVAILABLE. WOULD YOU BE WILLING TO RETURN 1 KIT BOX? I COULD SEND A REPLACEMENT. LOT 0289298. CUSTOMER WILL SEND RETURN. HOW WAS THE SPECIMEN COLLECTED? DID IT FOLLOW THE DUAL-NARES COLLECTION METHOD. DESCRIBED IN THE PRODUCT INSERT? YES, BOTH NARES. WHAT TYPE OF SWAB WAS USED TO COLLECT THE SPECIMEN? WAS THE ONE INCLUDED IN THE KIT? SWAB PROVIDED WITH KIT. WAS ANY TRANSPORT MEDIA USED? (THIS WOULD BE OUTSIDE PI CLAIMS) NO. WHAT DATE WAS THE SPECIMEN COLLECTED? 4 SPECIMENS ON (B)(6) 2020. WHAT DATE WAS THE SPECIMEN RUN? SAME DAY OF COLLECTION. WAS PATIENT SYMPTOMATIC OR ASYMPTOMATIC? 3 WERE ASYMPTOMATIC. 1 HAS BRONCHITIS THAT HAS BEEN TESTED MULTIPLE TIMES AND RESULTS WERE NEGATIVE. SCREENING TEST NO KNOWN EXPOSURE? TESTING WAS ROUTINE TESTING SCREENING. SCREENING TEST - KNOWN EXPOSURE THAT IS CURRENTLY ASYMPTOMATIC? N/A. ASYMPTOMATIC BUT DR RECOMMENDED TESTING? N/A. HOW WAS IT DETERMINED TO BE DISCREPANT? CUSTOMER USED THEIR OTHER TEST METHOD, ABBOTT IDNOW. COMPARISON TO ANOTHER METHOD? YES. CUSTOMER SENT SWAB FOR PCR TESTING FOR SYMPTOMATIC STAFF MEMBER ON (B)(6) 2020. PROVIDE DETAIL. REPEATED SAMPLE? (SEE BELOW) USED ABBOTT IDNOW. HOW DID THEY COMPLETE THE REPEAT TEST? 2ND SWAB WAS COLLECTED AND TESTED DIFFERENT METHOD. WAS AN ADDITIONAL SWAB COLLECTED? YES. DID THEY PROCESS THE SAME SWAB IN A 2ND REAGENT TUBE? DID THEY USE THE LEFTOVER EXTRACTION REAGENT FROM THE REAGENT TUBE ON A NEW CARTRIDGE? N/A. (B)(4). CUSTOMER PROBLEM: CUSTOMER REPORTS FOUR FALSE POSITIVE RESULTS WHILE USING CAT 256082 LOT 0289298. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER STATES THE GOT FOUR POSITIVE RESULTS USING THE VERITOR. CUSTOMER STATES THEY HAD PREVIOUSLY REPORTED THE SAME ISSUE WITH OTHER SPECIMENS. SEE CASE (B)(4). PER CUSTOMER, SPECIMENS WERE RECOLLECTED AND REPEATED ABBOTT ID NOW AND RESULTS WERE NEGATIVE. CUSTOMER PROVIDED ANSWERS TO QUESTIONNAIRE. CUSTOMER STATES THEY NEVER RECEIVED THE REPLACEMENT ANALYZER AND KIT FROM THE PREVIOUS CASE. C. POFF AUTHORIZED ANALYZER AND KIT REPLACEMENTS. NEXT STEPS (IF NECESSARY): DOCUMENT COMPLAINT. REQUEST FOC AND RETURNS. RESOLUTION ACHIEVED (Y/N)? : N.QUANTITY RECEIVED AND QUANTITY AFFECTED: UNKNOWN QUANTITY RECEIVED, 4 SPECIMENS AFFECTED. SHIPMENT METHOD (DIRECTLY OR VIA DISTRIBUTOR): DISTRIBUTOR. IF IT IS A DISTRIBUTOR WHO IS IT? (B)(4). PHOTOS OR RETURNS REQUESTED? REQUESTED RETURNS. (B)(4). REPLACEMENTS OR CREDIT REQUESTED : REPLACEMENTS. FOLLOW UP REQUIRED (Y/N)? Y. IF CONSUMABLE IS TESTED ON BD INSTRUMENTATION, LIST SERIAL NUMBERS: FOLLOW UP EMAIL SENT TO CUSTOMER. TIME STAMP (IF APPLICABLE): N/A. INDICATION THAT CUSTOMER IS INDUSTRIAL INDU (IF APPLICABLE): N/A. IS A LETTER SIGNED BY QUALITY REQUIRED (Y/N)? : Y, SEE (B)(4). REVIEWED SMAX CASE HISTORY: Y. HELP LIGHTNING ATTEMPT: N. HELP LIGHTNING SUCCESS: N. (B)(4). CALL ACTIVITY COMMENT: CUSTOMER REPORTS FOUR FALSE POSITIVE RESULTS WHILE USING CAT 256082 LOT 0289298. (B)(4). CUSTOMER REPORTS FOUR FALSE POSITIVE RESULTS WHILE USING CAT 256082.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27709 | BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ | CORONAVIRUS ANTIGEN DETECTION SYSTEM | QKP | BECTON, DICKINSON & CO. (SPARKS) | 0289298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |