FDA Device recall Z-0266-2025
remel BactiDrop Acridine Orange, REF 21502, 50 per package
- FDA Device
- Class II
- ongoing
- Published 2024-11-06
On 2024-11-06 the FDA classified a Class II recall of remel BactiDrop Acridine Orange, REF 21502, 50 per package by Remel, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0266-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-20 |
| Published | 2024-11-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Remel |
| Distribution | IL, IN, MN, NE, SD, TX, VA, WA |
Product
remel BactiDrop Acridine Orange, REF 21502, 50 per package.
Reason
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.
Identifiers
| code_info | Lot 733100, Exp. 2025-04-04; UDI-DI 848838000447. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0266-2025%22
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