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

FDA Recall Z-1315-2014 · Posted 2014-04-02

Recalling FirmRoche Diagnostics Operations, Inc.

Recall StatusTerminated

Date Initiated2014-02-28

Date Terminated2018-01-10

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032311ROCHE DIAGNOSTICS OMNI S ANALYZERRoche Diagnostics Corp. · 2003-10-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.