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.
- Company
- Diagnostica Stago, Inc.
- Recall Initiated
- April 13, 2005
- Posted
- August 30, 2005
- Terminated
- October 3, 2006
- Recall Number
- Z-1419-05
- Quantity
- 740 kits
- Firm Location
- Parsippany, NJ
Reason for Recall
Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent.
Distribution
The firm distributed this product to 32 clinics/laboratories/hospitals nationwide.
Lot / Code Info
Cat. No. 00599 Lot Number 041755 exp. 06/06.
Root Cause
Other
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.
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