May

2018

cobas b 221<2>Roche OMNI S2 system Cl II

Company:Roche Diagnostics Corporation
Date of Enforcement Report 5/9/2018
Class lI:

PRODUCT

cobas b 221<2>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-1610-2018

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

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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cobas b 221<2>Roche OMNI S2 system Cl II

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