Z-0311-2012

Roche Cobas c 111 Analyzer The Roche Cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of...

Name: Z-0311-2012 Roche Cobas c 111 Analyzer The Roche Cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of...
Creator: Roche Diagnostics Operations, Inc.
Published: 2011-10-18
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2011-10-18 / Terminated / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of Roche Cobas c 111 Analyzer The Roche Cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and... on 2011-10-18. The reason FDA records is "Internal investigations have revealed a potential printer malfunction on the Cobas c 111 analyzer, where one or more numbers or characters can be missing on the hard copy result printout, or the printer may skip leaving...". 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-0311-2012
Status: Terminated
Initiated: 2011-10-18
Posted: 2011-11-30
Terminated: 2013-02-21
Recalling firm: Roche Diagnostics GmbH
Product: Roche Cobas c 111 Analyzer The Roche Cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Internal investigations have revealed a potential printer malfunction on the Cobas c 111 analyzer, where one or more numbers or characters can be missing on the hard copy result printout, or the printer may skip leaving blanks which may result in an incorrect print layout. The missing number of characters can be in any position, therefore it could be in the middle of a result, (e.g. 48.53 mmol in
Root cause tag: software
FDA root cause: Software design
Action: Roche Diagnostics Operations, Inc sent a Urgent Medical Device Correction dated October 18, 2011, via UPS Ground (receipt required) to all affected customers and one distribution center, with instructions to disable the Auto Print Result feature until new software is available. All printed results will need to be confirmed against the results indicated on the display screen. Questions are to be directed to Roche Diagnostics Technical Support at 1-800 428-2336,
Quantity in commerce: 135
Distribution: Worldwide Distribution - USA including West Virginia and Texas.
Product codes and lots: Serial Numbers 50865, 50626, 50798, 50731, 50654, 50541, 51023, 50946, 50989, 50634, 50506, 50251, 50887, 50948, 50453, 50688, 51111, 50997, 51122, 50244, 50790, 50475, 50597, 50740, 50656, 50793, 51086, 50999, 51146, 50635, 50744, 50586, 50632, 50846, 1167, 50693, 50787, 50670, 50672, 51128, 50941, 50562, 50788, 50547, 51003, 50624, 50677, 50678, 50814, 51015, 50687, 50680, 50894, 50560, 51004, 50247, 50538, 51118, 50926, 50847, 50841, 51127, 50741, 50764, 50633, 51106, 51116, 50201, 51124, 50612, 51088, 50576, 51016, 50689, 50681, 50424, 51126, 50959, 50878, 50784, 50661, 50761, 50452, 50450, 50290, 50947, 51327, 50630, 50985, 50763, 50319, 50984, 50250, 50549, 50925, 50844, 50660, 50845, 50683, 50735, 51056, 50463, 50775, 50840, 50734, 50655, 50843, 50758, 50852, 50539, 50651, 50653, 50657, 50964, 50563, 50742, 50738, 50727, 50934, 50561, 50803, 51000, 51107, 50686, 50815, 50649, 50470, 50759, 50644, 51053, 50739, 50595, 51087, 50575, and 50679.

Product code JJE

K071211Class IICobas C 111 AnalyzerRoche Diagnostics / cleared 2007-07-30

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)