# FDA recall Z-1368-2019

> **Roche Diagnostics Corporation** · Class II · device recall initiated 2019-02-04.

## Product

Cobas¿ infinity central lab IT solution   Material Number: 07154003001     Calculator/Data Processing Module, For Clinical Use

## Reason for recall

Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality control (QC) alarm when one should be present. If the QC is out of range on the stand-by bottle and it is not removed from the system, there is a potential that when the status of the Standby bottle changes from the Standby bottle to the Current bottle status, QC alarms will not be displayed next to the sample result.

## Distribution

US Distribution to states of: AL, AZ, CA, GA, IA, MO, NJ, NY, SC, TN and TX.

## Key facts

- **Recall number:** Z-1368-2019
- **Recalling firm:** Roche Diagnostics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-04
- **Report date:** 2019-05-29
- **Termination date:** 2020-09-16

- **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-1368-2019

## Citation

> AI Analytics. FDA recall Z-1368-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1368-2019. Source: US FDA. Licensed CC0.

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