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Kamiya Biomedical Company, LLC Recall 91030

Description: K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013

Kamiya Biomedical Company, LLC Recall 91030 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0271-2023
Event ID91030
Event DescriptionK-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
Product TypeDevices
DistributionWorldwide - US Nationwide distribution in the states of FL, NC, TX, TN, PA, CA, NY, IL, MA and the country of Czech Republic.
Recall ReasonIgA Reagent may start showing cloudiness over time, which can affect assay performance.
Device Classification20221130
Device Code InfoUDI-DI: 00816426020092, Lot/ Expiration Date: H180/ 2023-01-31, K181/ 2023-03-31, N182/ 2023-06-30, D283/ 2023-09-30
Center Classification Date20221121
Recall Initiation Date20220928
Recalling FirmKamiya Biomedical Company, LLC
Initial Notification Letter
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