Device product
remel BactiDrop Acridine Orange, REF 21502, 50 per package.
Z-0266-2025
Product summary
- Firm
- Remel, Inc
- Event
- Event 95458
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 29 kits
- Official record key
device-enforcement:Z-0266-2025
Official wording
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.
Code information: Lot 733100, Exp. 2025-04-04; UDI-DI 848838000447.
Distribution pattern: 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.
Derived failure modes
-
Potency or specification failure
out-of-specification