🔍 RecallPedia

BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD

Class I - Dangerous
🏥 Medical Devices Recalled: February 21, 2023 Bio-Rad Laboratories Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot # 301481; UDI GTIN: 00847865000857
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Bio-Rad Laboratories, Inc.
Reason for Recall:
Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8  96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1  98.8%). The reduction in specificity may lead to an increase in the number of false positives.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD

Product Codes/Lot Numbers:

Lot # 301481; UDI GTIN: 00847865000857

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1377-2023

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