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:
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
Get notified
Receive notifications for new and updated recalls and alerts by category.