PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica S
FDA device recall Z-1419-05 · posted 2005-08-30 · Terminated
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- Reason for recall
- Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent.
- Action taken
- On 4/13/2005, recall notification letters were sent to all customers and instructed them to stop using the kits and to dispose of the kits according to local regulations.
- Root cause
- Other
- Status
- Terminated
- Product code
- GGW
- Quantity affected
- 740 kits
- Distribution
- The firm distributed this product to 32 clinics/laboratories/hospitals nationwide.
- Date initiated
- 2005-04-13
- Date posted
- 2005-08-30
- Date terminated
- 2006-10-03
- 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 |
|---|---|---|
| PTT-LA TEST KIT (K921684) | American Bioproducts Co. | 1992-06-09 |