Health product recall

ACL Elite Coagulation Analyzers

Last updated

Summary

Product
ACL Elite Coagulation Analyzers
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
ACL Elite Pro Coagulation Analyzer version 04.00.00 or 03.01.04 0001000311
ACL Elite Coagulation Analyzer version 04.00.00 or 03.01.04 0000880311

Issue

Werfen is releasing a mandatory test library upgrade on the ACL Elite/Elite Pro (test library 02.05.00). This is a follow up to phase 1 of the recall for of the removal of Hemosil ® Liquid Anti-Xa (pn 0020302600 and 0020302601) on the ACL Elite/Elite Pro. This mandatory library release, among other features, removes the test definition for Hemosil Liquid Anti-Xa (pn 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments.

Recall start date: February 3, 2023

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
Healthcare
Recall class
Type II
Identification number
RA-73110