Z-0538-05

Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13

Name: Z-0538-05 Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13
Creator: Dade Behring , Inc.
Published: 2004-12-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-12-03 / Terminated

FDA source

Dade Behring , Inc. began a recall of Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13 on 2004-12-03. The reason FDA records is "decrease in product stability after reconstitution and reduced stability on board certain instrument systems". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0538-05
Status: Terminated
Initiated: 2004-12-03
Posted: 2005-02-15
Terminated: 2005-10-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.
Product code: DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Reason for recall: decrease in product stability after reconstitution and reduced stability on board certain instrument systems
FDA root cause: Other
Action: The recalling firm issued a recall letter to their customers informing them of the problem and the need to use internal quality controls with the analyzers. The letter instructed customer to discard lot # 544545 and reduce the stability for the other lot numbers involved.
Quantity in commerce: 25381 units
Distribution: The product was shipped nationwide to medical facilities.
Product codes and lots: Lot numbers 544531 to 544548 and 544502 to 544504.

Product code DAP

K041438Class IIAdvanced D-Dimer AssayDade Behring, Inc. / cleared 2004-08-11

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)