Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact
FDA device recall Z-2650-2014 · posted 2014-09-16 · Terminated
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- Reason for recall
- Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.
- Action taken
- Diagnostica Stago sent a "Quality Information" letter/Customer Acknowledgement form to its customers. The letter identified the product, problem, and actions to be taken by the customers. For additional information and further support contact the Diagnostica Stago Hotline at 800-725-0607.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- KFF
- Quantity affected
- 514 kits
- Distribution
- Distributed USA (nationwide) and the country of Canada.
- Date initiated
- 2014-07-18
- Date posted
- 2014-09-16
- Date terminated
- 2015-01-16
- 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 |
|---|---|---|
| STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH (K111822) | Diagnostica Stago, Inc. | 2011-10-26 |