CLASS II ONGOING Device recall · Reported 6 Nov 2024 · FDA Enforcement Report
BactiDrop Acridine Orange recalled by Remel
Remel is recalling BactiDrop Acridine Orange, distributed in 8 states. The recall was initiated on 20 Sep 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0266-2025
- FDA event ID
- 95458
- Recalling firm
- Remel, Lenexa, KS
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Sep 2024
- FDA classified
- 30 Oct 2024
- Reported
- 6 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 20 Sep 2024 | Recall initiated by company | |
| 30 Oct 2024 | Classified by FDA | +40 days |
| 6 Nov 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
remel BactiDrop Acridine Orange, REF 21502, 50 per package.
Where it was 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.
IllinoisIndianaMinnesotaNebraskaSouth DakotaTexasVirginiaWashington
Questions about this recall
Why was it 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.
Which lots are affected?
Lot 733100, Exp. 2025-04-04; UDI-DI 848838000447.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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