Health product recall

Alinity and Architect A1C Reagent Kit

Brand(s)
Last updated

Summary

Product
Alinity and Architect A1C Reagent Kit
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare
Industry

Affected products

Affected products Lot or serial number Model or catalog number
Alinity C Hemoglobin A1C Reagent Kit 61658UQ01 59779UQ05 60229UQ07 61011UQ10 61349UQ01 60540UQ09 59561UQ04 08P4320
Architect Hemoglobin A1C Reagent 60535UQ08 59588UQ04 61066UQ11 59868UQ05 60237UQ08 60698UQ09 60880UQ10 61246UQ01 60138UQ07 61250UQ01 59900UQ06 4P52-20

Issue

This recall is to inform of a potential for falsely elevated hemoglobin %A1C and hemoglobin A1C patient results to be generated using the architect hemoglobin A1C assay when analyzing whole blood or hemolysate samples with poor sample integrity, due to micro-clots and particulate matter, associated with low total hemoglobin values. to address this issue, a revision to the total hemoglobin low linearity value for the architect hemoglobin a1c whole blood and hemolysate applications has been implemented.

Recall start date: June 15, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Abbott GmbH

Max-Planck-Ring 2, Wiesbaden, Germany, 65205

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-64283