FDA-Device2024-11-06Class II
remel BactiDrop Acridine Orange, REF 21502, 50 per package.
Remel, Inc
Hazard
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.
Sold states
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.
Affected count
29 kits
Manufactured in
12076 Santa Fe Trail Dr, N/A, Lenexa, KS, United States
Products
remel BactiDrop Acridine Orange, REF 21502, 50 per package.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0266-2025Don't want to check this manually?
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