Z-0165-2009

Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and...

Name: Z-0165-2009 Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and...
Creator: Roche Diagnostics Corp.
Published: 2008-06-24
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2008-06-24 / Terminated / root cause: software

FDA source

Roche Diagnostics Corp. began a recall of Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001 on 2008-06-24. The reason FDA records is "A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly". 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-0165-2009
Status: Terminated
Initiated: 2008-06-24
Posted: 2008-10-22
Terminated: 2009-10-22
Recalling firm: Roche Diagnostics GmbH
Product: Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly.
Root cause tag: software
FDA root cause: Other
Action: The consignees were notified of the problem via letter dated 6/24/08 and were provided instructions for a workaround.
Distribution: Nationwide Distribution --- including states of Florida, New Jersey and North Carolina.
Product codes and lots: All units with software version 08-02.

Product code JJE

K961481Class IElecsys 2010 AnalyzerBoehringer Mannheim Corp. / cleared 1996-06-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)