BactiDrop Acridine Orange (Remel) – Color Change Issue (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
remel BactiDrop Acridine Orange, REF 21502, 50 per package.
Brand
Remel, Inc
Lot Codes / Batch Numbers
Lot 733100, Exp. 2025-04-04, UDI-DI 848838000447.
Products Sold
Lot 733100, Exp. 2025-04-04; UDI-DI 848838000447.
Remel, Inc is recalling remel BactiDrop Acridine Orange, REF 21502, 50 per package. due to A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain res. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The recalling firm issued letters dated 9/18/2024 on 9/20/2024 via first class mail. The letter explained the reason for recall, risk to health, product distribution information, and actions to be taken by the consignee, which included destroying any remaining inventory of the affected lot number and completion and return of the Acknowledgement Form indicating the number of units destroyed. The form was to be returned via email. The notice was to be passed onto all who need to be aware within the consignee's organization or to any organization where the affected products have been transferred.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, IN, MN, NE, SD, TX, VA, WA
Page updated: Jan 10, 2026