HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot N0705526 UDI: 08426950632887 ***Updated 3/3/22*** Firm has expanded recall to include the following lot: N0806224
- 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:
- Instrumentation Laboratory
- Reason for Recall:
- The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Product Codes/Lot Numbers:
Lot N0705526 UDI: 08426950632887 ***Updated 3/3/22*** Firm has expanded recall to include the following lot: N0806224
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0276-2022
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