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Open, Classified

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

FDA Recall Z-0271-2023 · Posted 2022-11-21

Recalling FirmKamiya Biomedical Company, LLC
Recall StatusOpen, Classified
Product CodeCFF
Date Initiated2022-09-28
Product Quantity165

Reason for Recall

IgA Reagent may start showing cloudiness over time, which can affect assay performance.

Firm Action

On 9/28/22, recall notices were sent to customers informing them to stop using affected kit lots and to return complete and partially used kits to the recalling firm. Further, if opaque turbidity is observed, or the controls of the affected assay are not within range, do not report the test results. Distributors are asked to contact their customers and to inform them of the recall. Alternately, distributors can send the recalling firm their customer list so the recalling firm can notify the customers directly. Complete and return the customer acknowledgement. The following firm contacts were provided: (206) 575-8068 and [email protected]

Root Cause

Under Investigation by firm

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993213K-ASSAY IGAKamiya Biomedical Co. · 1999-11-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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