Recall Z-0064-2015— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-0064-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-12

Class III · Terminated

Class III FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2014-09-12, terminated 2018-01-10. It names one FDA 510(k) clearance: K032311. Product: 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.. Reason: 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..

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class III
Status: Terminated
Initiated: 2014-09-12
Terminated: 2018-01-10
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K032311 — ROCHE DIAGNOSTICS OMNI S ANALYZERRoche Diagnostics Corp.·cleared 2003-10-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.