remel BactiDrop Acridine Orange, REF 21502, 50 per package recallZ-0266-2025 · Remel, Inc · initiated Sep 20, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Remel, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0266-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 20, 2024
- Posted by the FDA
- Oct 30, 2024
- Recalling firm
- Remel, Inc
- Quantity
- 29 kits
- Product code
- JFO
- FDA submissions
- K920974
- 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.
Product description
remel BactiDrop Acridine Orange, REF 21502, 50 per package.
Code information (models, lots, serial numbers)
Lot 733100, Exp. 2025-04-04; UDI-DI 848838000447.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- REMEL R01144Remel, Inc. · Culture Media, Selective And Non-Differential1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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