Roche Diagnostics Operations, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0064-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: September 12, 2014

Date Posted: October 22, 2014

Recall Number: Z-0064-2015

Event ID: 69173

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.

Status: Terminated

Product Quantity: 492 devicees

Code Information:

Model/Catalog/Part Number: 1. 03337103001 2. 03337111001 3. 03337154001 4. 03337138001 5. 03337120001 6. 03337146001 7. 03337111692 8. 03337138692 9. 03337154692

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.

Voluntary or Mandated:

Voluntary: Firm initiated