FDAFDA · Food and drugs·Recall number Z-1612-2018
cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 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.
Published May 9, 2018 · Recall initiated: February 22, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Diagnostics Corporation
- Distributor
- USA ( nationwide)
- Lot
- Catalog numbers: 3337154001 and 3337154692 UDI: 04015630018345
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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