Bioplex 2200 Anti-CCP System recall in Canada: Performance issue
In plain language
This recall involves the Bioplex 2200 Anti-CCP System, including calibrator sets and system anti-CCP, sold in Canada. It's being recalled because of a performance issue that could lead to incorrect diagnosis of rheumatoid arthritis. Healthcare professionals should stop using the affected products and follow the return steps in the official notice.
What to do
- Stop using the affected products immediately.
- Check the lot and model numbers of your Bioplex 2200 Anti-CCP System.
- Contact Bio-Rad Laboratories (Canada) Ltd. for further instructions.
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Affected products
Bioplex 2200 Anti-CCP Calibrator Set
Model: 663-3200
Lot: 53727
Bioplex 2200 System Anti-CCP
Model: 665-3250
Lot: 301481
Why this matters
Incorrect diagnosis risk
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: 301481, 53727
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 663-3200, 665-3250
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Incorrect diagnosis risk
What should consumers do?
Stop using the affected products immediately. Check the lot and model numbers of your Bioplex 2200 Anti-CCP System. Contact Bio-Rad Laboratories (Canada) Ltd. for further instructions.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Incorrect diagnosis risk
When was this product recalled?
This product was recalled on March 9, 2023.
Is the Bio-Rad Laboratories, Inc. brand affected by this recall?
Yes, Bio-Rad Laboratories, Inc. products are affected by this recall. This recall involves the Bioplex 2200 Anti-CCP System, including calibrator sets and system anti-CCP, sold in Canada. It's being recalled because of a performance issue that could lead to incorrect diagnosis of rheumatoid arthritis. Healthcare professionals should stop using the affected products and follow the return steps in the official notice.