Medical Diagnostic Stain Product Recalled for Out-of-Specification Color Change
Remel, Inc is recalling 29 kits of remel BactiDrop Acridine Orange after discovery that the solution can change color during use, resulting in out-of-specification fluorescent staining results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a functional defect that compromises diagnostic accuracy. While no illnesses or injuries have been reported, the out-of-specification staining results represent a risk of diagnostic error that could harm patients.
Plain-English summary
Remel, Inc is recalling 29 kits of remel BactiDrop Acridine Orange (REF 21502) due to a color change issue affecting the product's staining performance. The solution in the dropper can change from orange-yellow to light yellow, resulting in out-of-specification fluorescent stain results.
The affected product was distributed to healthcare facilities in Illinois, Indiana, Minnesota, Nebraska, South Dakota, Texas, Virginia, Washington, and the United Kingdom. The specific affected lot is 733100 with an expiration date of April 4, 2025.
Customers who have this product should stop using it and contact Remel, Inc for instructions on obtaining a replacement or refund. The out-of-specification staining results may compromise the accuracy of diagnostic procedures using this stain.
The recalled product
- Product
- remel BactiDrop Acridine Orange, REF 21502, 50 per package.
- Manufacturer
- Remel, Inc
- Affected units
- 29
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot 733100
- Exp. 2025-04-04
- UDI-DI 848838000447.
Distribution
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