K-ASSAY IgA Immunoturbidimetric Assay recall
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
Why was K-ASSAY IgA Immunoturbidimetric Assay recalled?
IgA Reagent may start showing cloudiness over time, which can affect assay performance.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00816426020092, Lot/ Expiration Date: H180/ 2023-01-31, K181/ 2023-03-31, N182/ 2023-06-30, D283/ 2023-09-30
- Product
- K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
- Recalling firm
- Kamiya Biomedical Company, LLC
- Quantity
- 165
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, NC, TX, TN, PA, CA, NY, IL, MA and the country of Czech Republic.
- Recall date
- November 30, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)