Class II

Medical Device Recall: remel BactiDrop Acridine Orange, REF 21502, 50 per package.

Remel, Inc · September 20, 2024

Reason for Recall

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.

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 Affected

IL, IN, MN, NE, SD, TX, VA, WA

Quantity Affected

29 kits

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0266-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.