Recall Z-1419-05 ยท GGW Test, Time, Partial Thromboplastin
Diagnostica Stago, Inc.
PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., Five Century Drive, Parsippany, NJ 07054.
| Date | Aug 30, 2005 (initiated Apr 13, 2005) |
| Status | Terminated |
| Reason | Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent. |
| Root cause | Other |
| Action | 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. |
| Quantity | 740 kits |
| Distribution | The firm distributed this product to 32 clinics/laboratories/hospitals nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K921684 | PTT-LA TEST KIT American Bioproducts Co., Jun 9, 1992 |