Recall Z-1610-2018 ยท CEM Electrode, Ion Specific, Potassium
Roche Diagnostics Corporation
cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and me
| Date | May 3, 2018 (initiated Feb 22, 2018) |
| Status | Terminated |
| Reason | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. |
| Root cause | Software design |
| Action | ROCHE sent an Urgent Medical Device Correction Letter dated February 22, 2018, via UPS to affected customers. Customers were instructed to complete the following: " 1) Use the Return to Setup and Exit buttons to ensure execution of scheduled AutoQC measurements as described in this Urgent Medical Device Correction (UMDC); 2) Check to see if the next scheduled AutoQC measurement is performed to ensure the AutoQC scheduler is working as expected; 3) If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site; 4) Complete the attache |
| Quantity | 1026 total products |
| Distribution | USA ( nationwide) |
| 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 |