Z-1611-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- February 22, 2018
- Termination Date
- November 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1026 total products
Product Description
Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 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.
Reason for Recall
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Distribution Pattern
USA ( nationwide)
Code Information
Catalog numbers: 3337138001 and 3337138692 UDI: 04015630018321