# FDA recall Z-2038-2023

> **Remel, Inc** · Class II · device recall initiated 2023-05-31.

## Product

Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503.  For In Vitro Diagnostic Use.

## Reason for recall

The test medium may not perform as intended.

## Distribution

Distribution was made nationwide, including Puerto Rico.  There was no foreign or military distribution.

## Key facts

- **Recall number:** Z-2038-2023
- **Recalling firm:** Remel, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-31
- **Report date:** 2023-07-05

- **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-2038-2023

## Citation

> AI Analytics. FDA recall Z-2038-2023. Retrieved 2026-06-13 from https://api.ai-analytics.org/recall/Z-2038-2023. Source: US FDA. Licensed CC0.

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