Bioplex 2200 Anti-CCP System
Brand(s)
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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