🔍 RecallPedia

BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack

Class I - Dangerous
🏥 Medical Devices Recalled: February 8, 2022 Bio-Rad Laboratories Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Catalog Number: 12000650 UDI GTIN Code: 03610520653012 Lot Numbers: 301336
  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:
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
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 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack

Product Codes/Lot Numbers:

Catalog Number: 12000650 UDI GTIN Code: 03610520653012 Lot Numbers: 301336

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0806-2022

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