Bioplex 2200 Anti-CCP System
Brand(s)
Last updated
Summary
Product
Bioplex 2200 Anti-CCP System
Issue
Medical devices - Performance issue
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
Get notified
Receive notifications for new and updated recalls and alerts by category.