Recall Z-1200-2025— Remel, Inc

Name: FDA recall Z-1200-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-13

Class II · Ongoing

Class II FDA medical device recall by Remel, Inc, initiated 2025-02-13. FDA's recall record names no specific 510(k) clearance for this event. Product: remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use. Reason: Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate..

Recalling firm: Remel, Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-02-13
Firm location: Lenexa, KS, United States

Product description

remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use

Reason for recall

Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.

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