# FDA recall Z-1158-2020

> **Roche Diagnostics Operations, Inc.** · Class II · device recall initiated 2020-01-07.

## Product

cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.

## Reason for recall

Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.

## Distribution

Distributed to customers in AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, and TN.

## Key facts

- **Recall number:** Z-1158-2020
- **Recalling firm:** Roche Diagnostics Operations, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-07
- **Report date:** 2020-02-19
- **Termination date:** 2020-10-15

- **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-1158-2020

## Citation

> AI Analytics. FDA recall Z-1158-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1158-2020. Source: US FDA. Licensed CC0.

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