FDAFDA · Food and drugs·Recall number Z-0266-2025
remel BactiDrop Acridine Orange, REF 21502, 50 per package.
Published November 6, 2024 · Recall initiated: September 20, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Remel, Inc
- Distributor
- 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.
- Lot
- Lot 733100, Exp. 2025-04-04; UDI-DI 848838000447.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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