Medical device recalls Moderate risk

Remel BLOOD AGAR MacCONKEY AGAR BIPLATE recalled over Listeria risk

Recall date
February 13, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Remel, Inc recalls remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
Recall number
Z-1200-2025
FDA classification
Class II
Brand / firm
Remel, Inc
Sold / distributed
US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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