# FDA recall Z-1613-2018

> **Roche Diagnostics Corporation** · Class II · device recall initiated 2018-02-22.

## Product

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

USA ( nationwide)

## Key facts

- **Recall number:** Z-1613-2018
- **Recalling firm:** Roche Diagnostics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-22
- **Report date:** 2018-05-09
- **Termination date:** 2019-11-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianapolis, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1613-2018

## Citation

> AI Analytics. FDA recall Z-1613-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1613-2018. Source: US FDA. Licensed CC0.

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