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 in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.
FDA Recall Z-0064-2015 · Posted 2014-10-10
Recalling FirmRoche Diagnostics Operations, Inc.
Recall StatusTerminated
Product CodeCHL
Date Initiated2014-09-12
Date Terminated2018-01-10
Product Quantity492 devicees
Reason for Recall
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.
Firm 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.
Root Cause
Labeling Change Control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.