Roche Diagnostics Operations, Inc.
Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems: 1. 03337103001, cobas b 221<1>Roche OMNI S1 system 2. 03337111001, cobas b 221<2>Roche OMNI S2 system 3. 03337154001,cobas b 221<6>Roche OMNI S6 system 4. 03337138001, cobas b 221<4>Roche OMNI S4 system Product Usage: Usage: Blood Gas and Electrolytes A
| Date | Apr 2, 2014 (initiated Feb 28, 2014) |
| Status | Terminated |
| Reason | Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially cause erroneous pH and/or sodium results. Other Ion parameters are not affected. |
| Root cause | Device Design |
| Action | Roche Diagnostics Operations sent an Urgent Medical Device Correction letter dated February 27, 2014 via UPS Ground (receipt required) to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the enclosed fax form and fax it to 1-888-345-0253. For questions contact Roche Customer Business Support Center at 1-800-428-5076. |
| Distribution | Worldwide Distribution - USA nationwide including PR and the country of Guam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032311 | ROCHE DIAGNOSTICS OMNI S ANALYZER Roche Diagnostics Corp., Oct 17, 2003 |