K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
- Company
- Kamiya Biomedical Company, Llc
- Recall Initiated
- September 28, 2022
- Posted
- November 21, 2022
- Recall Number
- Z-0271-2023
- Quantity
- 165
- Firm Location
- Tukwila, WA
Reason for Recall
IgA Reagent may start showing cloudiness over time, which can affect assay performance.
Distribution
Worldwide - US Nationwide distribution in the states of FL, NC, TX, TN, PA, CA, NY, IL, MA and the country of Czech Republic.
Lot / Code Info
UDI-DI: 00816426020092, Lot/ Expiration Date: H180/ 2023-01-31, K181/ 2023-03-31, N182/ 2023-06-30, D283/ 2023-09-30
Root Cause
Under Investigation by firm
Action Taken
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