Z-0271-2023Class II

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

Name: Z-0271-2023 K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
Creator: Kamiya Biomedical Company, LLC
Published: 2022-09-28
License: https://open.fda.gov/license/

Kamiya Biomedical Company, LLC / initiated 2022-09-28 / Open, Classified

FDA source

Kamiya Biomedical Company, LLC began a recall of K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013 on 2022-09-28. FDA classified it as Class II and gives the reason as "IgA Reagent may start showing cloudiness over time, which can affect assay performance". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0271-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-28
Posted: 2022-11-21
Recalling firm: Kamiya Biomedical Company, LLC
Product: K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
Product code: CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Reason for recall: IgA Reagent may start showing cloudiness over time, which can affect assay performance.
FDA root cause: Under Investigation by 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]
Quantity in commerce: 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.
Product codes and lots: UDI-DI: 00816426020092, Lot/ Expiration Date: H180/ 2023-01-31, K181/ 2023-03-31, N182/ 2023-06-30, D283/ 2023-09-30

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0271-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0271-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-21

Product code CFF

K993213Class IIK-Assay IgaKamiya Biomedical Co. / cleared 1999-11-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)