remel BactiDrop Acridine Orange, REF 21502, 50 per package.
FDA device recall Z-0266-2025 · posted 2024-10-30 · Open, Classified
Recall details
- Recalling firm
- Remel, Inc
- 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.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JFO
- Quantity affected
- 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.
- Date initiated
- 2024-09-20
- Date posted
- 2024-10-30
- Location
- Lenexa, KS
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BACTIDROP ACRIDINE ORANGE (K920974) | Remel Co. | 1992-06-19 |