Z-0271-2023 Class II Ongoing
FDA device recall Z-0271-2023 was initiated by Kamiya Biomedical Company, LLC on September 28, 2022 and is designated Class II. Reason for recall: IgA Reagent may start showing cloudiness over time, which can affect assay performance. The recall status is ongoing. Affected quantity: 165.
Recall Details
- Product Type
- Devices
- Report Date
- November 30, 2022
- Initiation Date
- September 28, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 165
Product Description
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
Reason for Recall
IgA Reagent may start showing cloudiness over time, which can affect assay performance.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of FL, NC, TX, TN, PA, CA, NY, IL, MA and the country of Czech Republic.
Code Information
UDI-DI: 00816426020092, Lot/ Expiration Date: H180/ 2023-01-31, K181/ 2023-03-31, N182/ 2023-06-30, D283/ 2023-09-30