Z-0576-2008

Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation...

Name: Z-0576-2008 Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation...
Creator: Roche Diagnostics Corp.
Published: 2007-12-04
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2007-12-04 / Terminated / root cause: software

FDA source

Roche Diagnostics Corp. began a recall of Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis, IN 46250 on 2007-12-04. The reason FDA records is "Incorrect results: CRP assays may be calculated using incorrect calibration parameters which could result in falsely high or falsely low patient results being reported". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0576-2008
Status: Terminated
Initiated: 2007-12-04
Posted: 2008-03-04
Terminated: 2008-08-04
Recalling firm: Roche Diagnostics GmbH
Product: Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis, IN 46250.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: Incorrect results: CRP assays may be calculated using incorrect calibration parameters which could result in falsely high or falsely low patient results being reported.
Root cause tag: software
FDA root cause: Software design
Action: Roche Diagnostics contacted the consignee by phone on 12/4/07 and by follow-up letter dated 12/4/07. The user was instructed to discontinue use of two CRP assays on this analyzer. The letter described a workaround and that a new revision of software, due out first quarter 2008, will fix this.
Quantity in commerce: 1
Distribution: USA Distribution in the state of Nebraska.
Product codes and lots: All cce and cc system configurations with core unit software version 02-03.

Product code JJY

K060373Class IICobas 6000 Series SystemRoche Diagnostics / cleared 2006-03-13

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)