Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478
Class I - DangerousWhat Should You Do?
- Check if you have this product: All lots impacted. Kit lot numbers: 40476255 & 64505255 expiration date 2021-08-03, Lot numbers: 89332257 & 05694257 expiration date 2021-11-10.
- 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:
- Siemens Healthcare Diagnostics, Inc
- Reason for Recall:
- Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478
Product Codes/Lot Numbers:
All lots impacted. Kit lot numbers: 40476255 & 64505255 expiration date 2021-08-03, Lot numbers: 89332257 & 05694257 expiration date 2021-11-10.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2424-2021
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