Z-0042-05

DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies

Name: Z-0042-05 DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies
Creator: Dade Behring , Inc.
Published: 2004-08-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-08-27 / Terminated

FDA source

Dade Behring , Inc. began a recall of DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies on 2004-08-27. The reason FDA records is "APTT determinations when using affected rotors may lead to incorrectly shortened times". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0042-05
Status: Terminated
Initiated: 2004-08-27
Posted: 2004-10-23
Terminated: 2005-05-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: APTT determinations when using affected rotors may lead to incorrectly shortened times
FDA root cause: Other
Action: The recalling firm issued a recall letter dated 8/27/04 to their direct accounts informing them of the problem. The recalling firm also sent instructions for a work around until a solution can be established.
Quantity in commerce: 7140 units
Distribution: The product was shipped to medical facilities nationwide. The product was shipped to one government facility in TN.
Product codes and lots: Lot numbers 57295, 57304, 57400, 57463, 57504, 57562, 57579, 57601, 57674, 57685, 57755, 57819, 57820, and 57832

Product code JPA

K011665Class IIBct SystemDade Behring, Inc. / cleared 2001-08-09

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)