FDA Device recall Z-1612-2018
cobas b 221<6>Roche OMNI S6 system
- FDA Device
- Class II
- terminated
- Published 2018-05-09
On 2018-05-09 the FDA classified a Class II recall of cobas b 221<6>Roche OMNI S6 system by Roche Diagnostics, citing the software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1612-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-22 |
| Published | 2018-05-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Diagnostics |
| Distribution | US |
Product
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.
Identifiers
| code_info | Catalog numbers: 3337154001 and 3337154692 UDI: 04015630018345 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1612-2018%22
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