FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP)
FDA device recall Z-1080-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- 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.
- Action taken
- Diagnostica Stago sent a letter dated 12/4/2002 along with effectiveness check form to all customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- DAP
- Quantity affected
- 965
- Distribution
- The firm distributed the product 220 direct accounts which include hospitals, clinics, and clinical laboratories. There are 9 VA accounts.
- Date initiated
- 2002-12-04
- Date posted
- 2004-07-20
- Date terminated
- 2004-07-14
- Location
- Parsippany, NJ
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