Z-1040-05

Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E

Name: Z-1040-05 Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E
Creator: Dade Behring , Inc.
Published: 2005-06-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2005-06-21 / Terminated

FDA source

Dade Behring , Inc. began a recall of Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E on 2005-06-21. The reason FDA records is "positive control shows weak agglutination reaction". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1040-05
Status: Terminated
Initiated: 2005-06-21
Posted: 2005-07-22
Terminated: 2006-05-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E
Product code: GHH Fibrin Split Products
Reason for recall: positive control shows weak agglutination reaction
FDA root cause: Other
Action: The recalling firm notified their customers on 6/21/05 via letter dated 6/17/05. The customers were instructed to discontinue the use of the affected lot and discard any remaining inventory.
Quantity in commerce: 364 kits
Distribution: The product was shipped to hospital laboratories nationwide. The product was also shipped to Hungary, Switzerland, Poland, Spain, Italy, Argentina, Columbia, Mexico, Panama, Phillipines, El Salvadore, and Taiwan.
Product codes and lots: Lot number P152010 exp 4/30/06.

Product code GHH

K872360Class IIData-Fi Fibrin(ogen) Degradation Prod.(fdp)det SetAmerican Dade / cleared 1987-07-06

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)