Z-0266-2025 Class II Ongoing
FDA device recall Z-0266-2025 was initiated by Remel, Inc on September 20, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 29 kits.
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2024
- Initiation Date
- September 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 kits
Product Description
remel BactiDrop Acridine Orange, REF 21502, 50 per package.
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 Pattern
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.
Code Information
Lot 733100, Exp. 2025-04-04; UDI-DI 848838000447.