Roche Diagnostics Operations, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1315-2014)

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, Model/Catalog/Part Number: 03111873180 as a part of the following systems: 1. 03337103001, cobas b 221<1>Roche OMNI S1 system 2. 03337111001, cobas b 221<2>Roche OMNI S2 system 3. 03337154001,cobas b 221<6>Roche OMNI S6 system 4. 03337138001, cobas b 221<4>Roche OMNI S4 system Product Usage: Usage: Blood Gas and Electrolytes Analyzer c. Classification Name: Fully automated Critical Care Analyzer for the measurement of pH, Blood gases, electrolytes, Hematocrit, hemoglobin, glucose, lactate, urea/BUN, total hemoglobin, Oxygen saturation, oxy - deoxycarboxy and methemoglobin

Product Classification:

Class II

Date Initiated: February 28, 2014

Date Posted: April 9, 2014

Recall Number: Z-1315-2014

Event ID: 67549

Reason for Recall:

Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially cause erroneous pH and/or sodium results. Other Ion parameters are not affected.

Status: Terminated

Product Quantity: N/A

Code Information:

all serial numbers

Distribution Pattern:

Worldwide Distribution - USA nationwide including PR and the country of Guam.

Voluntary or Mandated:

Voluntary: Firm initiated