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Class 2 Device Recall KASSAY IgA Immunoturbidimetric Assay |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
September 28, 2022 |
Date Posted |
November 21, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0271-2023 |
Recall Event ID |
91030 |
510(K)Number |
K993213
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Product Classification |
Immunoelectrophoretic, immunoglobulins, (g, a, m) - Product Code CFF
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Product |
K-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
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For Additional Information Contact |
206-575-8068
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Manufacturer Reason for Recall |
IgA Reagent may start showing cloudiness over time, which can affect assay performance.
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FDA Determined Cause 2 |
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 quality@k-assay.com |
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. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = CFF and Original Applicant = KAMIYA BIOMEDICAL CO.
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