Health product recall

Bioplex 2200 Anti-CCP System

Brand(s)
Bio-Rad Laboratories, Inc.
Last updated

Summary

Product
Bioplex 2200 Anti-CCP System
Issue
Medical devices - Performance
What to do

BIO-RAD LABORATORIES (CANADA) LTD.
DIAGNOSTICS GROUP
CDGCANADA_TECHNICALSERVICES@BIO-RAD.COM

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Bioplex 2200 Anti-CCP Calibrator Set

53727

663-3200

Bioplex 2200 System Anti-CCP

301481

665-3250

Issue

Bio-Rad Laboratories has received reports of discrepant results with the md lot # 301481 #53727. False positive Anti-CCP results may lead to incorrect diagnosis of rheumatoid arthritis and unnecessary medical treatment. 

Recall start date: February 22, 2023

Additional information

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

Bio-Rad Laboratories, Inc.

4000 Alfred Nobel Drive, Hercules, California, United States, 94547

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73118

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Date modified: