FDA Medical Device · Z-1610-2018

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.

Class II · Terminated

The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.

Affected lots / codes — check yours against this3337111001 and 3337111692 UDI: 04015630018307

Recalling firm: Roche Diagnostics Corporation, Indianapolis, IN
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 1026 total products
Distribution: USA ( nationwide)
Recall initiated: February 22, 2018
Classified: May 3, 2018
Terminated: November 15, 2019
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1610-2018%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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