Z-0266-2025Class II

remel BactiDrop Acridine Orange, REF 21502, 50 per package

Name: Z-0266-2025 remel BactiDrop Acridine Orange, REF 21502, 50 per package
Creator: Remel, Inc
Published: 2024-09-20
License: https://open.fda.gov/license/

Remel Inc / initiated 2024-09-20 / Open, Classified

FDA source

Remel, Inc began a recall of remel BactiDrop Acridine Orange, REF 21502, 50 per package on 2024-09-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0266-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-20
Posted: 2024-10-30
Recalling firm: Remel Inc
Product: remel BactiDrop Acridine Orange, REF 21502, 50 per package.
Product code: JFO Fluorometric, Calcium
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.
FDA root cause: Under Investigation by firm
Action: The recalling firm issued letters dated 9/18/2024 on 9/20/2024 via first class mail. The letter explained the reason for recall, risk to health, product distribution information, and actions to be taken by the consignee, which included destroying any remaining inventory of the affected lot number and completion and return of the Acknowledgement Form indicating the number of units destroyed. The form was to be returned via email. The notice was to be passed onto all who need to be aware within the consignee's organization or to any organization where the affected products have been transferred.
Quantity in commerce: 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.
Product codes and lots: Lot 733100, Exp. 2025-04-04; UDI-DI 848838000447.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0266-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0266-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-30

Product code JFO

K920974Class IIBactidrop Acridine OrangeRemel Co. / cleared 1992-06-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)