FDA Recall Terminated

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

Recall: Z-1315-2014 · Initiated February 28, 2014

Recall

Recall Number: Z-1315-2014
Event Number: 67549
Firm: Roche Diagnostics Operations, Inc.
FEI Number: 1823260
Status: Terminated
Root Cause: Device Design
Initiated: February 28, 2014
Posted: April 2, 2014
Terminated: January 10, 2018
Address: 9115 Hague Rd, Indianapolis, IN, 46256-1025

Description

Reason

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.

Action

Roche Diagnostics Operations sent an Urgent Medical Device Correction letter dated February 27, 2014 via UPS Ground (receipt required) to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the enclosed fax form and fax it to 1-888-345-0253. For questions contact Roche Customer Business Support Center at 1-800-428-5076.

Distribution

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