Company: Roche Diagnostics Corporation
Date of Enforcement Report 5/9/2018
Class II:
PRODUCT
cobas b 221<4>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 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. Recall Number: Z-1611-2018
REASON
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate..
RECALLING FIRM/MANUFACTURER
HRoche Diagnostics Corporation, Indianapolis, IN 2/22/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1026 total products
DISTRIBUTION
Nationwide