ACL Elite Coagulation Analyzers
Brand(s)
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
Get notified
Receive notifications for new and updated recalls and alerts by category.