FDA Enforcement
Class II
Terminated
cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 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-1613-2018
·
Reported May 9, 2018
Enforcement
- Recall Number
- Z-1613-2018
- 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 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 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: 3313522001 and 3313522692
Distribution
USA ( nationwide)
Quantity
1026 total products