FDAClass IINovember 6, 2024

remel BactiDrop Acridine Orange recall

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

Why was remel BactiDrop Acridine Orange 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 733100, Exp. 2025-04-04; UDI-DI 848838000447.

Product
remel BactiDrop Acridine Orange, REF 21502, 50 per package.
Recalling firm
Remel, Inc
Quantity
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.
Recall date
November 6, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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