Z-0868-2008

Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay analyzer; Catalog numbers...

Name: Z-0868-2008 Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay analyzer; Catalog numbers...
Creator: Roche Diagnostics Corp.
Published: 2008-03-21
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2008-03-21 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay analyzer; Catalog numbers 04998642001 and 03617505001. Intended for qualitative and... on 2008-03-21. The reason FDA records is "Possible mismatch between patient and result". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0868-2008
Status: Terminated
Initiated: 2008-03-21
Posted: 2008-08-13
Terminated: 2009-11-18
Recalling firm: Roche Diagnostics GmbH
Product: Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay analyzer; Catalog numbers 04998642001 and 03617505001. Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Possible mismatch between patient and result.
FDA root cause: Process change control
Action: Consignees were notified via Urgent Medical Device Correction letter dated 3/21/08, which instructed them to not manually order QC test selections while the system is in operation mode and that they can only manually order QC when the system is in Stand-by mode. Consignees are instructed to consult with their physicians or pathologist to determine specific clinical implications for their patients. The firm states that this issue will be resolved in the next version of software.
Quantity in commerce: 11 of all models.
Distribution: Nationwide Distribution --- including states of Florida, Georgia, Indiana, 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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)