# FDA recall Z-1947-2025

> **Remel, Inc** · Class II · device recall initiated 2025-05-01.

## Product

Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device

## Reason for recall

Product may have an off color affecting perfomance

## Distribution

Worldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the countries of  Canada, UK.

## Key facts

- **Recall number:** Z-1947-2025
- **Recalling firm:** Remel, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-01
- **Report date:** 2025-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lenexa, KS, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1947-2025

## Citation

> AI Analytics. FDA recall Z-1947-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1947-2025. Source: US FDA. Licensed CC0.

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