Z-1305-04

Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit

Name: Z-1305-04 Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit
Creator: Dade Behring , Inc.
Published: 2004-06-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-06-07 / Terminated / root cause: manufacturing process

FDA source

Dade Behring , Inc. began a recall of Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit on 2004-06-07. The reason FDA records is "Customers have reported a high rate of instrument error flags and calibration issues when using affected reagent". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1305-04
Status: Terminated
Initiated: 2004-06-07
Posted: 2004-07-31
Terminated: 2005-01-06
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit.
Product code: KFF Assay, Heparin
Reason for recall: Customers have reported a high rate of instrument error flags and calibration issues when using affected reagent.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The recalling firm sent a recalling letter to the direct accounts informing them that the affected lots can not be used for heparin determinations. Direct account were instructed
Quantity in commerce: 781 kits
Distribution: The heparin reagent, which is a component of a test kit, wasdistributed to direct accounts in the following states: AZ, CA, CO, FL, IA, IL, IN, KY, OH, MA, MD, MI, MN, NC, NE, NJ, NM, NY, PA,TN, TX, WI, WV. Further, there are foreign countries also affected in this recall action, as listed: Australia, Canada, France, Finland, Germany, Israel, Italy, Spain, United kingdom, Spain
Product codes and lots: Lots 541428, 541429, expiration date of Nov 2006

Product code KFF

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)