Recall Z-1377-2012 ยท DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Wako Chemicals USA, Inc.
Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in part ***Manufactured by: Wako Pure Chemical Industries, Ltd. 1-2, Doshomachi 3-Chome, Chuo-Ku Osaka 540-8605, Japan***Distributed by: Wako Chemicals USA, Inc. /Wako Diagnostics 1600 Bellwood Road Richmond, VA 23237*** Product Usage: The Lp(a) calibrator is intended to be used with the W
| Date | Apr 6, 2012 (initiated Jan 30, 2012) |
| Status | Terminated |
| Reason | In-vitro diagnostic kit calibrator is defective and could impact patient profile for cardiovascular disease. |
| Root cause | Device Design |
| Action | Wako Diagnostics notified its customers by telephone on January 26, 2012 and sent an Urgent Medical Device Recall letter dated January 30, 2012 to inform them of the product recall. The notifications identified the affected product, problem and actions to be taken. Consignees were requested to: 1) Complete and sign the attached Return Materials Authorization (RMA) Form to receive replacement material and 2) Package the recalled Product to be returned and send to the address listed on the RMA form. For questions call Technical Support Team at 1-877-714-1924. |
| Quantity | 10 kits |
| Distribution | The product had been sold to 2 customers in the US. |
| 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 |