FDA Enforcement
Class II
Terminated
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.
Recall: Z-1612-2018
·
Reported May 9, 2018
Enforcement
- Recall Number
- Z-1612-2018
- Event ID
- 79676
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Roche Diagnostics Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 9, 2018
- Initiation Date
- February 22, 2018
- Classification Date
- May 3, 2018
- Termination Date
- November 15, 2019
- Address
- 9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States
Description
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.
Reason
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Code Info
Catalog numbers: 3337154001 and 3337154692 UDI: 04015630018345
Distribution
USA ( nationwide)
Quantity
1026 total products