FDA Medical Device Recalls (openFDA)
Remel, Inc: remel BactiDrop Acridine Orange, REF 21502, 50 per package.
- Recall number
- Z-0266-2025
- Recalling firm
- Remel, Inc
- Product
- remel BactiDrop Acridine Orange, REF 21502, 50 per package.
- Status
- Open, Classified
- Initiated
- 2024-09-20
- Posted
- 2024-10-30
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 29 kits
- 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.
- Lot, serial or model codes
- Lot 733100, Exp. 2025-04-04; UDI-DI 848838000447.
- 510(k) numbers
- ["K920974"]
- PMA numbers
- not on file
- Product code
- JFO
- Firm FEI
- 1924669
- Firm city
- Lenexa
- Firm state
- KS
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28