ALINITY I B12 REAGENT KIT
Received Sep 22, 2025 · Event occurred Sep 5, 2025
Report 3005094123-2025-00467 · MDR key 23116302
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P67-32
Lot number
72282UD00
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED IMPRECISE ALINITY I B12 RESULTS FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) INITIAL RESULT (B)(6) 2025 174 PG/ML. REPEATED RESULTS: (B)(6) 2025, 1102 PG/ML (B)(6), (B)(6) 2025, 1014 PG/ML (B)(6), (B)(6) 2025 ,510 PG/ML (B)(6) , (B)(6) 2025, 486 / 483 / 474 PG/ML (B)(6), NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
SECTION H6 MEDICAL DEVICE PROBLEM CODE WAS UPDATED FROM A090809 TO A0908. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I B12 REAGENT DID NOT IDENTIFY ANY TREND REGARDING COMMONALITIES FOR LOT NUMBER AND ISSUE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES ASSOCIATED WITH LOT NUMBER 72282UD00 AND COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF ALINITY I B12 REAGENTS IN THE FIELD WAS REVIEWED USING DATA FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN RESULT FOR THE LOT WAS ANALYZED AND FOUND TO BE COMPARABLE TO ALL OTHER LOTS IN THE FIELD AND CONFIRMS NO SYSTEMIC ISSUE FOR THE LOT. A REVIEW OF THE LABELLING ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I B12 ASSAY, LOT 72282UD00 WAS IDENTIFIED.
Additional Manufacturer Narrative
A1 PATIENT IDENTIFIER: THE COMPLETE SAMPLE ID B)(6). E1 PHONE NUMBER: COMPLETE PHONE NUMBER IS (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P67-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P67-21 / 31, WITH NUMBER 510K K121314.
Description of Event or Problem
THE CUSTOMER OBSERVED IMPRECISE ALINITY I B12 RESULTS FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) INITIAL RESULT (B)(6) 2025 174 PG/ML REPEATED RESULTS: (B)(6) 2025 1102 PG/ML (B)(6). (B)(6) 2025 1014 PG/ML (B)(6). (B)(6) 2025 510 PG/ML (B)(6). (B)(6) 2025 486 / 483 / 474 PG/ML (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.