Acl Top Cts
Brand(s)
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 products - Medical devices - 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