ALINITY I B12 REAGENT KIT
Received Dec 9, 2024 · Event occurred Nov 27, 2024
Report 3005094123-2024-00635 · MDR key 20886018
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P67-32
Lot number
65284UD01
Product problems
- High Test Results
- 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 RESULTS FOR THE ALINITY I B12 ASSAY FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID: NL7546 REAGENT LOT 65284UD00 B12 RESULTS: 232.63 PG/ML ON (B)(6)2024 REPORTED OUT BELIEVED TO BE CORRECT. 331.36 PG/ML ON (B)(6)2024, 236.00 PG/ML ON (B)(6)2024. REFERENCE RANGE FOR B12 187-883 PG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
THE REAGENT SIZE CODE WAS UPDATED ON 01JAN2025. UPDATED FIELD D4-LOT# FROM 65284UD00 TO 65284UD01 AND FIELD D4-PRIMARY UDI NUMBER FROM (B)(4).
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY I B12 REAGENT, LIST 07P67-32, ABBOTT IRELAND DIAGNOSTICS DIVISION, LONGFORD, IRELAND TO THE ALINITY I PROCESSING MODULE, LIST 03R65-01, ABBOTT LABORATORIES, IRVING, TEXAS, USA. MDR NUMBER 3016438761-2025-00071-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.
Description of Event or Problem
THE CUSTOMER OBSERVED IMPRECISE RESULTS FOR THE ALINITY I B12 ASSAY FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID: (B)(6), REAGENT LOT 65284UD00. B12 RESULTS: -> 232.63 PG/ML ON (B)(6) 2024 REPORTED OUT BELIEVED TO BE CORRECT. -> 331.36 PG/ML ON (B)(6) 2024. -> 236.00 PG/ML ON (B)(6) 2024. REFERENCE RANGE FOR B12 187-883 PG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER OBSERVED IMPRECISE RESULTS FOR THE ALINITY I B12 ASSAY FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID: (B)(6) REAGENT LOT 65284UD01: B12 RESULTS: 232.63 PG/ML ON (B)(6) 2024 REPORTED OUT BELIEVED TO BE CORRECT. 331.36 PG/ML ON (B)(6) 2024. 236.00 PG/ML ON (B)(6) 2024. REFERENCE RANGE FOR B12 187-883 PG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.