Remel, Inc: Device Recall

Recall #Z-0266-2025 · 09/20/2024

Class II: Risk

Recall Details

Recall Number
Z-0266-2025
Classification
Class II
Product Type
Device
Recalling Firm
Remel, Inc
Status
Ongoing
Date Initiated
09/20/2024
Location
Lenexa, KS, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
29 kits

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.

Product Description

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

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.

Other Recalls by Remel, Inc

View all recalls by Remel, Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.