Z-0007-05

BC Thrombin Reagent . Thrombin Time Test

Name: Z-0007-05 BC Thrombin Reagent . Thrombin Time Test
Creator: Dade Behring , Inc.
Published: 2004-07-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-07-21 / Terminated

FDA source

Dade Behring , Inc. began a recall of BC Thrombin Reagent . Thrombin Time Test on 2004-07-21. The reason FDA records is "The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0007-05
Status: Terminated
Initiated: 2004-07-21
Posted: 2004-10-05
Terminated: 2004-12-15
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: BC Thrombin Reagent . Thrombin Time Test
Product code: GJA Test, Thrombin Time
Reason for recall: The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin
FDA root cause: Other
Action: The recalling firm issued a recall letter dated 7/21/04 to their accounts informing them of the problem and the need to discard the product.
Quantity in commerce: 3942 kits
Distribution: The products were shipped to medical facilities in CT, FL, IA, IL, NJ, PA, and WI. The products were also shipped to Austria, Bosnia, Croatia, Hungry, Germany, Poland, Spain, RussiaFrance, Italy, Australia, Brazil, Canada, Saudi Arabia, El Salvador, and Turkey.
Product codes and lots: Lot 540624, Lot 540625, and Lot 540626

Product code GJA

K970645Class IIBc Thrombin ReagentBehring Diagnostics, Inc. / cleared 1997-05-19

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)