STA Liatest Free Protein S For in vitro diagnostic use. 2-8 degrees C Distributed in the USA by: Diagnostica Stago, Inc.
FDA device recall Z-1072-2007 · posted 2007-08-09 · Terminated
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- Reason for recall
- Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit.
- Action taken
- Customers were sent a Product Recall Notification on May 8, 2007 by first class mail labeled " Recall notice, Open Immediately"
- Root cause
- Other
- Status
- Terminated
- Product code
- GGP
- Quantity affected
- 365 units
- Distribution
- Medical facilities nationwide
- Date initiated
- 2007-05-08
- Date posted
- 2007-08-09
- Date terminated
- 2010-10-13
- Location
- Parsippany, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIATEST PROTEIN S KIT (K912468) | American Bioproducts Co. | 1991-10-02 |