Recall Z-0940-04 ยท DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Kamiya Biomedical Company
K-Assay Lp(a) Control
| Date | Jul 20, 2004 (initiated Mar 29, 2004) |
| Status | Terminated |
| Reason | Assay result not consistent with the assigned control value |
| Root cause | Other |
| Action | On 3/30/04 customers were faxed a letter and mailed a letter. The letter advises of the problem, requests the customer to discontinue using product, and requests return of the product. |
| Quantity | 16 |
| Distribution | The firm distributed product to 3 distributors, 1 each in CA, PA, and MN; and 2 labs, 1 each in GA and MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023853 | K-ASSAY LP(A) CONTROLS Kamiya Biomedical Co., Dec 13, 2002 |