—#210333

Product

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

FDA product code: JFO — Fluorometric, Calcium
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K920974
Affected lot / code info: Lot 733100, Exp. 2025-04-04; UDI-DI 848838000447.

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Remel, Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-09-20
Posted by FDA: 2024-10-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210333. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.