Z-1613-2018 Class II Terminated
FDA device recall Z-1613-2018 was initiated by Roche Diagnostics Corporation on February 22, 2018 and is designated Class II. Reason for recall: The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. The recall status is terminated (terminated November 15, 2019). Affected quantity: 1026 total products.
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 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 for Recall
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Distribution Pattern
USA ( nationwide)
Code Information
Catalog numbers: 3313522001 and 3313522692