Health product recall

UniCel DxI 600 Access Immunoassay System-Total T4 Assay

Brand(s)
BECKMAN COULTER, INC.
Last updated

Summary

Product
UniCel DxI 600 Access Immunoassay System-Total T4 Assay
Issue
Medical devices - Performance
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

UniCel DxI 600 Access Immunoassay System-Total T4 Assay

538815

33805

UniCel DxI 600 Access Immunoassay System-Total T4 Assay

539243

33805

UniCel DxI 600 Access Immunoassay System-Total T4 Assay

538729

33805

UniCel DxI 600 Access Immunoassay System-Total T4 Assay

538898

33805

UniCel DxI 600 Access Immunoassay System-Total T4 Assay

539107

33805

Issue

Access Total T4 calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. In the worst-case scenario, there is a medium safety risk associated with this issue due to the potential to cause false low patient results.
 

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
Recall date
Identification number
RA-81777

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