Recall Z-0266-2025— Remel, Inc

Name: FDA recall Z-0266-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-20

Class II · Ongoing

Class II FDA medical device recall by Remel, Inc, initiated 2024-09-20. It names one FDA 510(k) clearance: K920974. Product: remel BactiDrop Acridine Orange, REF 21502, 50 per package.. 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 results..

Recalling firm: Remel, Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-09-20
Firm location: Lenexa, KS, United States

510(k) clearances named in this recall

1 on FDA's record

K920974 — BACTIDROP ACRIDINE ORANGERemel Co.·cleared 1992-06-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.