Health product recall

Access System - Total T4 Assay

Last updated

Summary

Product
Access System - Total T4 Assay
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 catalogue number
Access System - Total T4 Assay 338555 338734 338958 338556 33800

Issue

Beckman Coulter has determined that the affected Access Total T4 reagent lots demonstrate an assay imprecision that is higher than expected. An unusual amount of precipitate may be observed in the Access Total T4 reagent packs.

Recall start date: February 5, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Beckman Coulter, Inc.
250 S. Kraemer Blvd., Brea, California, United States, 92821
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75075

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