Recall Z-2330-2015— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-2330-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-24

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2015-06-24, terminated 2016-01-12. It names one FDA 510(k) clearance: K032311. Product: S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes 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, bilirubin, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.. Reason: The affected S2 fluid packs may generate a transponder error when the fluid pack is loaded on to the cobas b 221 system. The error prevents the fluid from being recognized by the system and the instrument cannot start measurements until the affected S2 Fluid Pack is replaced..

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-06-24
Terminated: 2016-01-12
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

S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes 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, bilirubin, 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 affected S2 fluid packs may generate a transponder error when the fluid pack is loaded on to the cobas b 221 system. The error prevents the fluid from being recognized by the system and the instrument cannot start measurements until the affected S2 Fluid Pack is replaced.

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