Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Class I - DangerousWhat Should You Do?
- Check if you have this product: Sold between 2019 and 2021
- 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:
- Stanbio Laboratory, LP
- Reason for Recall:
- The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated. An erroneous result could lead to sub-optimal nutrition supplementation for patients (infants)
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Product Codes/Lot Numbers:
Sold between 2019 and 2021
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0905-2022
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