Recall Z-1409-06 ยท MMY Lipoprotein, Low Density, Removal
Wako Chemicals, USA Inc
Lp(a) Calibrator, Cat No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box ,Waco Chemicals USA, Inc., 1600 Bellwood Road Richmond, VA 23237, Manufactured by: Wako Pure Chemical Industries, Ltd. Osaka Japan
| Date | Aug 25, 2006 (initiated Jul 6, 2006) |
| Status | Terminated |
| Reason | Unexpected low cholesterol results-The Cholesterol calibrator (Lp(a)) component of the in vitro diagnostic kit for cholesterol testing, has provided patient results lower than the correct value. |
| Root cause | Process control |
| Action | The recalling firm notified consignees by phone and e-mail with an attached letter dated 07/06/06. The notification, flagged as ''Important Device Recall'' advised consignees to stop using the recalled product and that Lp(a) results showed a decrease in value of approximately 10% when the identified lots are used. Consignees were requested to return the enclosed response form for replacement product. |
| Quantity | 136 kits |
| Distribution | The product was sold to one distributor and direct medical accounts Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981446 | WAKO AUTOKIT LP(A) Wako Chemicals USA, Inc., Mar 9, 1999 |