—#125702

Product

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

510(k) numbers: K032311
Affected lot / code info: all serial numbers

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

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

Timeline

Recall initiated: 2014-02-28
Posted by FDA: 2014-04-02
Terminated: 2018-01-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125702. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.