Recall Z-0064-2015 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Roche Diagnostics Operations, Inc.
Omni Micro-electrode/reference electrode for cobas b221 analyzer. 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 methemoglobin i
| Date | Oct 10, 2014 (initiated Sep 12, 2014) |
| Status | Terminated |
| Reason | The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments. In addition, the reference ranges are different when comparing with corresponding ranges listed in the Instructions for Use for the analyzer and the reference literature source. |
| Root cause | Labeling Change Control |
| Action | The Urgent Medical Device Correction will be sent via UPS Ground (receipt required) to the consignee list. The Urgent Medical Device Correction will be sent via UPS Ground (receipt required) to the consignee list. Consignees are instructed as follows: " Check the current set of reference values on your cobas b 221 blood gas system and, if appropriate, change the reference ranges accordingly. " If you have not established your own reference ranges, please follow the instructions in the Workaround section of the UMDC or contact the Roche Support Network Customer Support Center. |
| Quantity | 492 devicees |
| Distribution | Nationwide Distribution including Puerto Rico and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, ME, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA and WI. |
| 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 |