Recall Z-1377-2012
Wako Chemicals USA, Inc. · initiated January 30, 2012
Product
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 Wako Autokit Lp(a) test to establish the points of reference that are used in the determination of Lp(a) in serum or plasma.
Codes / lots: Lot No.: DJ427, Exp 08-31-12
Reason for recall
In-vitro diagnostic kit calibrator is defective and could impact patient profile for cardiovascular disease.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1377-2012
- Initiated
- January 30, 2012
- Posted by FDA
- April 6, 2012
- Terminated
- May 2, 2012
- Product code
- DFC – Lipoprotein, Low-Density, Antigen, Antiserum, Control
- Quantity
- 10 kits
- Distribution
- The product had been sold to 2 customers in the US.
- Recalling firm
- Wako Chemicals USA, Inc., Richmond, VA