# FDA recall Z-1425-2021

> **Remel Inc** · Class II · device recall initiated 2021-03-10.

## Product

Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503     Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.

## Reason for recall

When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1425-2021
- **Recalling firm:** Remel Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-03-10
- **Report date:** 2021-04-21

- **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-1425-2021

## Citation

> AI Analytics. FDA recall Z-1425-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1425-2021. Source: US FDA. Licensed CC0.

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