FDA recall Z-0266-2025

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2024-09-20

Report date

2024-11-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lenexa, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0266-2025