Recall Z-1611-2018— Roche Diagnostics Corporation
Class II · Terminated
Class II FDA medical device recall by Roche Diagnostics Corporation, initiated 2018-02-22, terminated 2019-11-15. It names one FDA 510(k) clearance: K032311. Product: 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: The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate..
- Recalling firm
- Roche Diagnostics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-22
- Terminated
- 2019-11-15
- Firm location
- Indianapolis, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.