Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
Class I - DangerousWhat Should You Do?
- Check if you have this product: All in-date lots: 190133, 190222 ***Updated 4/6/2020*** New lot added: 100066 ***Updated 9/4/20*** New lot added: 100168
- 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:
- The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
Product Codes/Lot Numbers:
All in-date lots: 190133, 190222 ***Updated 4/6/2020*** New lot added: 100066 ***Updated 9/4/20*** New lot added: 100168
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1599-2020
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