Health product recall

Acl Top Cts

Last updated

Summary

Product
Acl Top Cts
Issue
Medical devices - Inaccurate test or measurement results
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Acl Top 500 Cts

All lots.

00000280040, 00000280040R

Acl Top 300 Cts

All lots.

00000280060R, 00000280060

Acl Top 550 Cts

All lots.

00000280045

Acl Top 350 Cts

All lots.

00000280065

Issue

We have become aware of a potential carryover issue that may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when hemosil liquid anti-xa reagent is used in the same run with both hemosil liquid antithrombin and hemosil q.f.a. thrombin (bovine).

Recall start date: Feb 22, 2022

Additional information

Details
Original published date: 2022-03-09
Alert / recall type
Health product recall
Category
Health product - Medical device - Haematology
Companies

Instrumentation Laboratory Co.

180 Hartwell Road, Bedford, Massachusetts

United States, 01730-2443

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63967