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Terminated

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.

FDA Recall Z-1080-04 · Posted 2004-07-20

Recalling FirmDiagnostica Stago, Inc.
Recall StatusTerminated
Product CodeDAP
Date Initiated2002-12-04
Date Terminated2004-07-14
Product Quantity965

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.

Firm Action

Diagnostica Stago sent a letter dated 12/4/2002 along with effectiveness check form to all customers.

Root Cause

Other

Distribution Pattern

The firm distributed the product 220 direct accounts which include hospitals, clinics, and clinical laboratories. There are 9 VA accounts.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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