Recall Z-0311-2012 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Operations, Inc.
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.
| Date | Nov 30, 2011 (initiated Oct 18, 2011) |
| Status | Terminated |
| Reason | 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 | 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 | 135 |
| Distribution | Worldwide Distribution - USA including West Virginia and Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071211 | COBAS C 111 ANALYZER Roche Diagnostics, Jul 30, 2007 |