ALINITY I TOTAL B-HCG REAGENT KIT
Report
- Report Number
- 3005094123-2025-00396
- Event Type
- Malfunction
- Date Received
- August 18, 2025
- Date of Event
- August 11, 2025
- Report Date
- October 27, 2025
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- DHA
- UDI-DI
- 00380740121518
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P51-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P51-21 / 7P51 -31, WITH 510K/PMA/BLA NUMBER K170317.
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. A1 - PATIENT IDENTIFIER: INITIAL: (B)(6) - UPDATED TO MULTIPLE TO PROVIDE 2 SAMPLE IDS ((B)(6) - TOTAL OF 2 PATIENTS) ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. B5 - DESCRIBE EVENT OR PROBLEM - UPDATED TO ADD ADDITIONAL PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P51-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P51-21 / 7P51 -31, WITH 510K/PMA/BLA NUMBER K170317.
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. A1 - PATIENT IDENTIFIER: UPDATED TO ADD ADDITIONAL SAMPLE IDS (B)(6) - 2 ADDITIONAL PATIENTS FOR A TOTAL OF 4 PATIENTS. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. B5 - DESCRIBE EVENT OR PROBLEM - UPDATED TO ADD ADDITIONAL PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P51-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P51-21 / 7P51 -31, WITH 510K/PMA/BLA NUMBER K170317.
AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY I TOTAL B-HCG, LIST NUMBER 07P51-30, ABBOTT IRELAND DIAGNOSTICS DIVISION, LONGFORD MANUFACTURING SITE TO ALINITY I PROCESSING MODULE, LIST NUMBER 03R65-01, ABBOTT LABORATORIES IRVING IA/CC MANUFACTURING SITE. MDR NUMBER 3016438761-2025-00623 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.
THE CUSTOMER REPORTED A FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT FOR ONE PATIENT SAMPLE GENERATED ON THE ALINITY I PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL B-HCG (RAN ON (B)(6)) = 43.24 MIU/ML (THIS RESULT RELEASED TO THE MEDICAL PROVIDER) THE PHYSICIAN QUESTIONED THIS RESULT, AND THE SAMPLE WAS RERUN OBTAINING A NEGATIVE RESULT. THE SAMPLE WAS RUN ON ANOTHER INSTRUMENT CONFIRMING A NEGATIVE RESULT. A NEW SAMPLE WAS TAKEN FROM THE PATIENT AND TESTED ON BOTH INSTRUMENTS AND GENERATED A NEGATIVE RESULT ON BOTH INSTRUMENTS. THE QC WAS WITHIN RANGE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
ON AUGUST 13, 2025, THE CUSTOMER PROVIDED A NEW PATIENT CASE FOR A FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT FOR ONE PATIENT SAMPLE GENERATED ON THE ALINITY I PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: TESTED ON (B)(6) 2025, SID (B)(6): INITIAL B-HCG (RAN ON (B)(6)) = 54.45 MIU/ML (RESULT NOT RELEASED) RERAN B-HCG ON ANOTHER INSTRUMENT AND GENERATED A NEGATIVE RESULT AND THIS RESULT WAS RELEASED TO THE MEDICAL PROVIDER. THE QUALITY CONTROL (QC) WAS WITHIN RANGE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
ON (B)(6) 2025, THE CUSTOMER REPORTED ADDITIONAL FALSE POSITIVE ALINITY I TOTAL B-HCG RESULTS FOR 2 ADDITIONAL PATIENTS. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025, SID (B)(6): INITIAL B-HCG RESULT = 28.36 MIU/ML; RERAN THE SAMPLE AND GENERATED A NEGATIVE RESULT. THE SAMPLE WAS RUN ON ANOTHER INSTRUMENT AND GENERATED A NEGATIVE B-HCG RESULT. THE DISCREPANT RESULT WAS NOT RELEASED TO THE MEDICAL PROVIDER. ON (B)(6) 2025, SID (B)(6) GENERATED AN INITIAL RESULT OF 63 MIU/ML. THE SAMPLE WAS RETESTED ON A DIFFERENT INSTRUMENT GENERATING A NEGATIVE RESULT. THE DISCREPANT RESULT WAS NOT RELEASED TO THE MEDICAL PROVIDER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
THE CUSTOMER REPORTED A FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT FOR ONE PATIENT SAMPLE GENERATED ON THE ALINITY I PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: INITIAL B-HCG (RAN ON (B)(6) = 43.24 MIU/ML (THIS RESULT RELEASED TO THE MEDICAL PROVIDER) THE PHYSICIAN QUESTIONED THIS RESULT, AND THE SAMPLE WAS RERUN OBTAINING A NEGATIVE RESULT. THE SAMPLE WAS RUN ON ANOTHER INSTRUMENT CONFIRMING A NEGATIVE RESULT. A NEW SAMPLE WAS TAKEN FROM THE PATIENT AND TESTED ON BOTH INSTRUMENTS AND GENERATED A NEGATIVE RESULT ON BOTH INSTRUMENTS ON (B)(6) 2025, THE CUSTOMER PROVIDED A NEW PATIENT CASE FOR A FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT FOR ONE PATIENT SAMPLE GENERATED ON THE ALINITY I PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: TESTED ON (B)(6) 2025, SID (B)(6): INITIAL B-HCG (RAN ON (B)(6) = 54.45 MIU/ML (RESULT NOT RELEASED) RERAN B-HCG ON ANOTHER INSTRUMENT AND GENERATED A NEGATIVE RESULT AND THIS RESULT WAS RELEASED TO THE MEDICAL PROVIDER. ON (B)(6) 2025, THE CUSTOMER REPORTED ADDITIONAL FALSE POSITIVE ALINITY I TOTAL B-HCG RESULTS FOR 2 ADDITIONAL PATIENTS. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025, SID (B)(6): INITIAL B-HCG RESULT = 28.36 MIU/ML; RERAN THE SAMPLE AND GENERATED A NEGATIVE RESULT. THE SAMPLE WAS RUN ON ANOTHER INSTRUMENT AND GENERATED A NEGATIVE B-HCG RESULT. THE DISCREPANT RESULT WAS NOT RELEASED TO THE MEDICAL PROVIDER. ON (B)(6) 2025, SID (B)(6) GENERATED AN INITIAL RESULT OF 63 MIU/ML. THE SAMPLE WAS RETESTED ON A DIFFERENT INSTRUMENT GENERATING A NEGATIVE RESULT. THE DISCREPANT RESULT WAS NOT RELEASED TO THE MEDICAL PROVIDER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2193778 | ALINITY I TOTAL B-HCG REAGENT KIT | SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN | DHA | ABBOTT IRELAND DIAGNOSTICS DIVISION | 71475UD00 | 00380740121518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01,(B)(6) |