Medical device recalls Moderate risk

Remel, Inc recalls remel BactiDrop Acridine Orange, REF 21502, 50 per package.

Recall date
September 20, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0266-2025
FDA classification
Class II
Brand / firm
Remel, Inc
Sold / distributed
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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

remel BactiDrop Acridine Orange, REF 21502, 50 per package.

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