Health product recall

Access System - Free T3 Assays

Last updated

Summary

Product
Access System - Free T3 Assays
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

Unicel DxI 600 Access Immunoassay System - Free T3 Assay

233968

A13422

Unicel DxI 800 Access Immunoassay System - Free T3 Assay

233968

A13422

Access System - Free T3 Assay

233968

A13422

Issue

Beckman Coulter has determined that Access Free T3 reagent lot 233968 included an insufficient concentration of blocking reagent. Patient samples tested with Access Free T3 reagent lot 233968 may demonstrate repeatable falsely elevated results, which are caused by insufficiently blocked interferents.

Recall start date: March 20, 2023

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-73409

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