ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 10309217
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 00630414479286 Lot Numbers: 9520531 Exp.Date: 2023-05-31; 9520341 Exp. Date: 2024-03-31
- 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:
- Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 10309217
Product Codes/Lot Numbers:
UDI-DI: 00630414479286 Lot Numbers: 9520531 Exp.Date: 2023-05-31; 9520341 Exp. Date: 2024-03-31
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1631-2023
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