Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot 416245 ***Updated 10/5/20*** 483123 ***Updated 8/5/22*** Additional released lots are subject to the same workaround: 46449, 50474,525510, and 568976
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Roche Diagnostics Operations, Inc.
- Reason for Recall:
- The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9 reagent, which may affect clinical interpretation.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
Product Codes/Lot Numbers:
Lot 416245 ***Updated 10/5/20*** 483123 ***Updated 8/5/22*** Additional released lots are subject to the same workaround: 46449, 50474,525510, and 568976
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1444-2020
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