The Recall Desk
HighFDA (Devices)·Z-1378-2023·Announced 2023-04-19

BioPlex 2200 Anti-CCP Reagent Kit recalled due to reduced test specificity

Bio-Rad is recalling BioPlex 2200 Anti-CCP reagent kits due to reduced specificity that may cause false positive results. Four customer complaints documented discrepant results during validation testing.

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: FDA Class II device with confirmed specificity reduction (94.5% vs. labeled 97.8%) and customer-reported performance issues. Increased risk of false positive diagnostic results. No illnesses, injuries, or hospitalizations reported, placing this at High severity: risk-of-harm from diagnostic inaccuracy without yet-reported injury.

Plain-English summary

Bio-Rad Laboratories, Inc. is recalling BioPlex 2200 Anti-CCP reagent kits (Lot 301481) distributed worldwide because the kits exhibit reduced test specificity compared to the labeled performance.

From November to December 2022, Bio-Rad received four customer complaints reporting discrepant results when comparing Lot 301481 results to previous lots during lot-to-lot validation. Internal testing confirmed the issue: Lot 301481 has a specificity of 94.5% (95% confidence interval 91.8–96.4%), lower than the labeled specificity of 97.8% (95% confidence interval 96.1–98.8%). This reduction in specificity may lead to an increased number of false positive results.

The affected products were distributed worldwide to the United States, Canada, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, Norway, and Sweden. Calibrator sets (Lot 53727) are included in the recall because they are lot-matched to the affected reagent kits, though Bio-Rad confirmed no performance issues with the calibrators themselves.

Healthcare facilities should contact Bio-Rad for information about returning the affected reagent kits and obtaining replacement product.

The recalled product

Product
BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
Manufacturer
Bio-Rad Laboratories, Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
225

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 # 53727
  • UDI GTIN: 00847865000819

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Bio-Rad Laboratories, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Bio-Rad Laboratories, Inc.

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