FDA Medical devices recall ·
remel BactiDrop Acridine Orange recall
- Recall number
- Z-0266-2025
- Date
- (initiated September 20, 2024)
- Company / brand
- Remel, Inc
12076 Santa Fe Trail Dr, Lenexa, KS, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 29 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
remel BactiDrop Acridine Orange, REF 21502, 50 per package.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot 733100, Exp. 2025-04-04; UDI-DI 848838000447.
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: Illinois Indiana Minnesota Nebraska South Dakota Texas Virginia Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0266-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.