Recall Z-0923-2011 ยท MGA Alpha-1 Microglobulin, Antigen, Antiserum, Control
Kamiya Biomedical Company, LLC
K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL, and 1 vial reagent 2, Antibody Reagent 50 mL. The product is packaged in a kit box along with with the package insert. The package insert is labeled in part: "K-ASSAY Alpha-1 Microglobulin...Cat. No. KAI-056...For the Quantitative Determination of human Alpha-1 Microglobulin in urine, serum, and plasma...
| Date | Jan 19, 2011 (initiated Sep 17, 2008) |
| Status | Terminated |
| Reason | Standardization of the reagent performance data did not match the standardization used to assign the calibrator values. |
| Root cause | Employee error |
| Action | Kamiya Biomedical Company, LLC sent an urgent medical Device Recall letter dated September 17, 2008, and the corrected package insert via e-mail. . The letter identified the product, the problem, and the action the customer should take. Customers were instructed to replace their previous package inserts with the corrected version and asked to sign and FAX the letter back once that had been completed. As one customer is also a distributor, the recalling firm told the this distributor's representative to advise their single customer of this correction and replace the package insert, and re |
| Quantity | 5 kits |
| Distribution | Kits were distributed to one laboratory in MN and to one distributor in PA who further distributed product to one customer. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.