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: 2022-06-23
Alert / recall type
Health product recall
Category
Health product - Medical device - 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