Roche Omni Micro-electrode Recall for Inconsistent Reference Values
Roche Diagnostics is recalling Omni Micro-electrodes for the cobas b221 analyzer because default reference values are inconsistent with other instruments and instructions.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard involves inconsistent reference values, which is a labeling/documentation issue rather than a direct physical injury risk.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 492 Omni Micro-electrode/reference electrodes intended for use with the cobas b221 analyzer. The recall was initiated because the default references for normal values are inconsistent between the cobas b221 and other blood gas instruments. Additionally, the reference ranges differ when compared with the corresponding ranges listed in the Instructions for Use for the analyzer and the reference literature source.
The affected devices were distributed nationwide, including Puerto Rico and Guam, and in 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. The specific model/catalog/part numbers involved are 03337103001, 03337111001, 03337154001, 03337138001, 03337120001, 03337146001, 03337111692, 03337138692, and 03337154692.
Healthcare facilities and users should stop using the affected Omni Micro-electrode/reference electrodes and contact Roche Diagnostics Operations, Inc. for further instructions regarding the recall.
The recalled product
- Product
- 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, lact
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
- Affected units
- 492
Distribution
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