Summary
The FDA issued a Class II for remel BactiDrop Acridine Orange, REF 21502, 50 per package. by Remel, Inc. Reason: A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain res.
Details
Source
Device Recall
External ID
Z-0266-2025
Action Date
2024-11-06
Status
Ongoing
Category
device
Product Description
remel BactiDrop Acridine Orange, REF 21502, 50 per package.
Lot/Code Info: Lot 733100, Exp. 2025-04-04; UDI-DI 848838000447.
Quantity Affected: 29 kits
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-20
Company
Lenexa, KS
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 243 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Remel, Inc has 25 FDA actions in our database, including 25 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Remel, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Remel, Inc have FDA actions?
Remel, Inc has 25 FDA actions in our database, including 25 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0266-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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