Recall Z-0271-2023 ยท CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Kamiya Biomedical Company, LLC
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
| Date | Nov 21, 2022 (initiated Sep 28, 2022) |
| Status | Open, Classified |
| Reason | IgA Reagent may start showing cloudiness over time, which can affect assay performance. |
| 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 p |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993213 | K-ASSAY IGA Kamiya Biomedical Co., Nov 23, 1999 |