Z-1080-04

FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation...

Name: Z-1080-04 FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation...
Creator: Diagnostica Stago, Inc.
Published: 2002-12-04
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2002-12-04 / Terminated

FDA source

Diagnostica Stago, Inc. began a recall of FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex... on 2002-12-04. The reason FDA records is "The FDP Plasma latex reagent (Reagent Vial 1) is more sensitive which may result in a weak agglutination at low concentration of FDPs". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1080-04
Status: Terminated
Initiated: 2002-12-04
Posted: 2004-07-20
Terminated: 2004-07-14
Recalling firm: Diagnostica Stago, Inc.
Product: 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.
Product code: DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
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.
FDA root cause: Other
Action: Diagnostica Stago sent a letter dated 12/4/2002 along with effectiveness check form to all customers.
Quantity in commerce: 965
Distribution: The firm distributed the product 220 direct accounts which include hospitals, clinics, and clinical laboratories. There are 9 VA accounts.
Product codes and lots: Lot 012823 Exp October 2003

Product code DAP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)