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U.S. Department of Health and Human Services

Class 2 Device Recall KASSAY IgA Immunoturbidimetric Assay

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 Class 2 Device Recall KASSAY IgA Immunoturbidimetric Assaysee related information
Date Initiated by FirmSeptember 28, 2022
Date PostedNovember 21, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0271-2023
Recall Event ID 91030
510(K)NumberK993213 
Product Classification Immunoelectrophoretic, immunoglobulins, (g, a, m) - Product Code CFF
ProductK-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
Code Information UDI-DI: 00816426020092, Lot/ Expiration Date: H180/ 2023-01-31, K181/ 2023-03-31, N182/ 2023-06-30, D283/ 2023-09-30
Recalling Firm/
Manufacturer		 Kamiya Biomedical Company, LLC
12779 Gateway Dr S
Tukwila WA 98168-3308
For Additional Information Contact
206-575-8068
Manufacturer Reason
for Recall		IgA Reagent may start showing cloudiness over time, which can affect assay performance.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 quality@k-assay.com
Quantity in Commerce165
DistributionWorldwide - US Nationwide distribution in the states of FL, NC, TX, TN, PA, CA, NY, IL, MA and the country of Czech Republic.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CFF
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