ELECSYS VITAMIN B12 II
Received Jun 21, 2022 · Event occurred May 26, 2022
Report 1823260-2022-01781 · MDR key 14752280
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsModel number
B12 G2Catalog number
07212771190
Lot number
58858302
Product problems
- Low Test Results
- Low Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE VITAMIN B12 G2 ELECSYS RESULTS FROM THE COBAS 6000 E601 MODULE SERIAL NUMBER: (B)(4). REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE CUSTOMER INSTITUTED INITIAL CONTROLS MUST BE PERFORMED ON ALL B12 REAGENT CASSETTES. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE INVESTIGATION CHECKED THE QC RESULTS ON DAY 1, DAY 7, DAY 14, AND DAY 21 FOR THREE REAGENT PACKS STORED ON THE ANALYZER. THE CONTROL RECOVERY WAS CLEARLY WITHIN THE SPECIFIED CONTROL ACCEPTANCE RANGES. NO PRODUCT PROBLEM WAS FOUND AND THE REAGENT MEETS SPECIFICATIONS.