# K032311: Roche Diagnostics Omni S Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Oct 17, 2003 after 81 days
- Product code: CEM (Electrode, Ion Specific, Potassium)
- Device class: 2
- Regulation: 21 CFR 862.1600
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940918 (1994). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990092: Avl Omni Modular Analyzer, Avl Scientific Corp. (1999) Summary page 1.
- K013373: Omni C Analyzer, Roche Diagnostics Corp. (2001) Summary page 1.

## Most influential descendants
- K111188: Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack, Roche Combitrol Plus B (2012), 0 descendants of its own

## Recalls of this device
- Feb 22, 2018 · Class II · Z-1611-2018: The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
- Feb 22, 2018 · Class II · Z-1613-2018: The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
- Feb 22, 2018 · Class II · Z-1610-2018: The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
- Feb 22, 2018 · Class II · Z-1612-2018: The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
- Oct 31, 2016 · Class II · Z-0673-2017: Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. QC measurement results can be affected as well. This issue is only detectable i
- Jun 24, 2015 · Class II · Z-2330-2015: The affected S2 fluid packs may generate a transponder error when the fluid pack is loaded on to the cobas b 221 system. The error prevents the fluid from being recognized by the system and the instru
- Dec 18, 2014 · Class II · Z-1041-2015: Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positive bias up to 39% at 4.1 mmol/l for the glucose measurement and 30% at 4.12 mmol/l for lactate. Urea re
- Sep 12, 2014 · Class III · Z-0064-2015: The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments. In addition, the reference ranges are different when comparing with corresponding ranges 
- Feb 28, 2014 · Class II · Z-1315-2014: Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially cause erroneous pH and/or sodium results. Other Ion parameters are not affected.

## Indications for use
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, P02, PC02, 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.

Source page: https://510kreport.com/device/K032311
Methodology: https://510kreport.com/methodology