Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0266-2025

September 20, 2024

Class II

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

    reason.potency_specification_failure · v1.0.0

    out-of-specification