K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
Class I - Dangerous 🏥 Medical Devices
Recalled: September 28, 2022 Kamiya Biomedical Company Other Medical Devices
Nationwide
What Should You Do?
- Check if you have this product: UDI-DI: 00816426020092, Lot/ Expiration Date: H180/ 2023-01-31, K181/ 2023-03-31, N182/ 2023-06-30, D283/ 2023-09-30
- 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:
- Kamiya Biomedical Company, LLC
- Reason for Recall:
- IgA Reagent may start showing cloudiness over time, which can affect assay performance.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
Product Codes/Lot Numbers:
UDI-DI: 00816426020092, Lot/ Expiration Date: H180/ 2023-01-31, K181/ 2023-03-31, N182/ 2023-06-30, D283/ 2023-09-30
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0271-2023
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