Public recall detail

Acl Top Cts

medium
Recall Safety notice
Quick summary

Quick summary: Acl Top Cts.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Acl Top Cts.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandINSTRUMENTATION LABORATORY CO.
ProductAcl Top Cts
IssueMedical devices - Inaccurate test or measurement results
Recall classType II
IdentificationRA-63967

Affected products

ProductAcl Top 500 Cts
LotAll lots.
Model00000280040, 00000280040R
Serial numberAll lots.
DescriptionAcl Top 500 Cts
ProductAcl Top 300 Cts
LotAll lots.
Model00000280060R, 00000280060
Serial numberAll lots.
DescriptionAcl Top 300 Cts
ProductAcl Top 550 Cts
LotAll lots.
Model00000280045
Serial numberAll lots.
DescriptionAcl Top 550 Cts
ProductAcl Top 350 Cts
LotAll lots.
Model00000280065
Serial numberAll lots.
DescriptionAcl Top 350 Cts

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
CategoryHealth products - Medical devices - Haematology
CompaniesInstrumentation Laboratory Co. 180 Hartwell Road, Bedford, Massachusetts United States, 01730-2443
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-63967
Background{}
CompaniesInstrumentation Laboratory Co. 180 Hartwell Road, Bedford, Massachusetts United States, 01730-2443
AudiencesGeneral public Health professionals Hospitals
Source updated2022-03-07

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

Official source Monitor products Back to recalls

Starting...

Related recalls

Similar recalls and safety notices.

Loading related recalls...