remel BactiDrop Acridine Orange, REF 21502, 50 per package.
- Company
- Remel Inc
- Recall Initiated
- September 20, 2024
- Posted
- October 30, 2024
- Recall Number
- Z-0266-2025
- Quantity
- 29 kits
- Firm Location
- Lenexa, KS
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.
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 / Code Info
Lot 733100, Exp. 2025-04-04; UDI-DI 848838000447.
Root Cause
Under Investigation by firm
Action Taken
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.