Health product recall

Alinity I Homocysteine Reagent Kit

Brand(s)
Last updated

Summary

Product
Alinity I Homocysteine Reagent Kit
Issue
Medical devices - Quality issue
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Alinity I Homocysteine Reagent Kit

11486UP00, 11466UP00, 11453UP00, 11485UP00, 11406UP00

09P2820

Issue

The purpose of this notification is to inform you of a product correction for the Alinity I Homocysteine Reagent Kits listed in the letter. Abbott has identified that some reagent kits produce suboptimal calibrations resulting in a downward shift of quality control results. If your laboratory has established statistically‐based control limits at each clinically relevant control level, your controls will detect the shift out of range. If quality control results do not meet the acceptance criteria defined by your laboratory, sample results may be suspect and should not be reported.

Recall start date: Mar 25, 2022

Additional information

Details
Original published date: 2022-04-07
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
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64044