# FDA recall Z-2444-2021

> **Roche Diagnostics Operations, Inc.** · Class II · device recall initiated 2021-06-24.

## Product

cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001

## Reason for recall

Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory Information System (LIS) as a false positive or negative result. It should be noted that the "correct" result would still be available on the instrument.

## Distribution

US Nationwide distribution

## Key facts

- **Recall number:** Z-2444-2021
- **Recalling firm:** Roche Diagnostics Operations, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-24
- **Report date:** 2021-09-22
- **Termination date:** 2023-07-21

- **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-2444-2021

## Citation

> AI Analytics. FDA recall Z-2444-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2444-2021. Source: US FDA. Licensed CC0.

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