Recall archive / FDA device enforcement
remel BactiDrop Acridine Orange, REF 21502, 50 per package. — FDA record Z-0266-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 20, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Remel, Inc
- Quantity
- 29 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0266-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot 733100, Exp. 2025-04-04; UDI-DI 848838000447. |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 6, 2024
- Recall initiation date
- Sep 20, 2024
- Center classification date
- Oct 30, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.