Health product recall

UniCel DxI 800 Access Immunoassay System

Last updated

Summary

Product
UniCel DxI 800 Access Immunoassay System
Issue
Medical devices - Increased risk or new adverse events
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or serial number

Model or catalog number

ACCESS IMMUNOASSAY ANALYZERS - CLASS 3

123468

81910

ACCESS SYSTEM - IMMUNOASSAY ANALYZERS CLASS 2

123468

81910

ACCESS SYSTEM - THYROGLOBULIN ANTIBODY II

124312

A32898

UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - INSTRUMENT REAGENTS

123468

81910

UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - SYSTEM REAGENTS

123468

81910

UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - THYROGLOBULIN ANTIBODY II

124312

A32898

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - SYSTEM REAGENTS

123468

81910

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - SYSTEM REAGENTS

123468

81910

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - THYROGLOBULIN ANTIBODY II]

124312

A32898

Issue

One shipment of the affected lot was frozen and thawed prior to shipment.

 

Recall date: 2021-10-07

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices
Companies

BECKMAN COULTER, INC.,

250 S. KRAEMER BLVD., BREA, CALIFORNIA

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63536

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