# FDA recall Z-0266-2025

> **Remel, Inc** · Class II · device recall initiated 2024-09-20.

## Product

remel BactiDrop Acridine Orange, REF 21502, 50 per package.

## Reason for recall

A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results.

## Distribution

Distribution was made to IL, IN, MN, NE, SD, TX, VA, and WA.  There was government distribution but no military distribution.  Foreign distribution was made to the United Kingdom.

## Key facts

- **Recall number:** Z-0266-2025
- **Recalling firm:** Remel, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-20
- **Report date:** 2024-11-06

- **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-0266-2025

## Citation

> AI Analytics. FDA recall Z-0266-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0266-2025. Source: US FDA. Licensed CC0.

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