Lp(a) Calibrator, Cat No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box ,Waco Chemicals USA, Inc., 1600
FDA device recall Z-1409-06 · posted 2006-08-25 · Terminated
Recall details
- Recalling firm
- Wako Chemicals, USA Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MMY
- Quantity affected
- 136 kits
- Distribution
- The product was sold to one distributor and direct medical accounts Nationwide.
- Date initiated
- 2006-07-06
- Date posted
- 2006-08-25
- Date terminated
- 2006-09-14
- Location
- Richmond, VA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WAKO AUTOKIT LP(A) (K981446) | Wako Chemicals USA, Inc. | 1999-03-09 |