FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies to FDP. The kit contains: 1 x1.3 mL vial of Reagent 1 (Latex), 1 x 20mL bottle of Reagent 2 (Buffer), 1 x 0.5mL vial of Reagent 3 (Negative Control), 1 x 0.5mL vial of Reagent 4 (Positive Control) and 10 test cards with mixing rods packaged in a predominantly white cardboard unit container. Distributed in the USA by Diagnostica Stago, Five Century Drive, Parsippany, NJ 07054.
- Company
- Diagnostica Stago, Inc.
- Recall Initiated
- December 4, 2002
- Posted
- July 20, 2004
- Terminated
- July 14, 2004
- Recall Number
- Z-1080-04
- Quantity
- 965
- Firm Location
- Parsippany, NJ
Reason for Recall
The FDP Plasma latex reagent (Reagent Vial 1) is more sensitive which may result in a weak agglutination at low concentration of FDPs.
Distribution
The firm distributed the product 220 direct accounts which include hospitals, clinics, and clinical laboratories. There are 9 VA accounts.
Lot / Code Info
Lot 012823 Exp October 2003
Root Cause
Other
Action Taken
Diagnostica Stago sent a letter dated 12/4/2002 along with effectiveness check form to all customers.
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