Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in part ***Ma
FDA device recall Z-1377-2012 · posted 2012-04-06 · Terminated
Recall details
- Recalling firm
- Wako Chemicals USA, Inc.
- Reason for recall
- In-vitro diagnostic kit calibrator is defective and could impact patient profile for cardiovascular disease.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DFC
- Quantity affected
- 10 kits
- Distribution
- The product had been sold to 2 customers in the US.
- Date initiated
- 2012-01-30
- Date posted
- 2012-04-06
- Date terminated
- 2012-05-02
- Location
- Richmond, VA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WAKO AUTOKIT LP(A) (K981446) | Wako Chemicals USA, Inc. | 1999-03-09 |