BioPlex 2200 Anti-CCP Reagent Pack Recalled for Reduced Diagnostic Specificity
Bio-Rad is recalling BioPlex 2200 Anti-CCP Reagent Pack, Lot 301481, because the test's specificity is lower than claimed, which may increase false positive results. The diagnostic kit was distributed worldwide including the US, Canada, and several European countries.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II diagnostic device recall with reduced test specificity that poses a risk of incorrect patient diagnosis through false positive results. Per the severity rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
Bio-Rad Laboratories is recalling BioPlex 2200 Anti-CCP Reagent Pack, Lot 301481. This in vitro diagnostic device is used in clinical laboratories to test for antibodies associated with rheumatoid arthritis. Approximately 1544 units were distributed.
The recall was issued due to reduced test specificity. Internal testing revealed the lot has 94.5% specificity compared to the 97.8% specificity stated in the product instructions. This reduction may increase the number of false positive results—patients without the condition being incorrectly identified as positive.
Bio-Rad received four customer complaints between November 30 and December 21, 2022, reporting discrepant results when validating this lot against previous lots. The affected kit lot was distributed worldwide including to the United States, Canada, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, Norway, and Sweden.
No patient illnesses or injuries have been reported. Clinical laboratories and healthcare facilities using this reagent lot should contact Bio-Rad Laboratories for guidance. Depending on the clinical context, facilities may need to consider revalidating previous test results generated from this specific lot.
The recalled product
- Product
- BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
- Manufacturer
- Bio-Rad Laboratories, Inc.
- Hazard
- false-positives
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 301481
- UDI GTIN: 00847865000857
Distribution
Distributed nationwide across the United States.
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