ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Per recall strategy.
- 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:
- A rare variant of TSH, identified in a small cluster of patients, is not detected.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Product Codes/Lot Numbers:
Per recall strategy.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1881-2013
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