FDA Device

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.

Hazard

Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent.

What You Should Do

Remedy

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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Products

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.
Brand
Diagnostica Stago, Inc.
UPC
Cat. No. 00599 Lot Number 041755 exp. 06/06.

Units Affected

740 kits

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