Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN:05055273203868 Batch/Lot Number: 2031EC Exp. Date: 28th Nov 23
- 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:
- Randox Laboratories Ltd.
- Reason for Recall:
- Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
Product Codes/Lot Numbers:
GTIN:05055273203868 Batch/Lot Number: 2031EC Exp. Date: 28th Nov 23
Distribution:
Distributed in: CA, IL, VA, WA, WI, PR
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2021-2023
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