ALINITY I B12 REAGENT KIT
Received Jun 14, 2021
Report 3005094123-2021-00111 · MDR key 11992570
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
A.i.d.d LongfordCatalog number
07P67-22
Lot number
22925UI00
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
COMPLETE INFORMATION FROM PATIENT IDENTIFIER: MULTIPLE = SID (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P67-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P67-21 / 31. 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 FALSELY ELEVATED ALINITY I B12 RESULTS FOR TWO PATIENTS. THE RESULTS PROVIDED WERE: (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM THE ALINITY I B12 ASSAY, LIST NUMBER 07P67-22 AND MANUFACTURING SITE A.I.D.D LONGFORD TO THE ALINITY I PROCESSING MODULE, LIST NUMBER 03R65-01, AND MANUFACTURING SITE ABBOTT GMBH. MDR NUMBER 3002809144-2021-00385-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.