K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
Reported: November 30, 2022 Initiated: September 28, 2022 #Z-0271-2023
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.
Details
- Recalling Firm
- Kamiya Biomedical Company, LLC
- Units Affected
- 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.
- Location
- Tukwila, WA
Frequently Asked Questions
What product was recalled? ▼
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013. Recalled by Kamiya Biomedical Company, LLC. Units affected: 165.
Why was this product recalled? ▼
IgA Reagent may start showing cloudiness over time, which can affect assay performance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 30, 2022. Severity: Moderate. Recall number: Z-0271-2023.
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