Medical device recalls

Palcam Agar Base recalled over Listeria risk

Recall date
August 2, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Acumedia Manufacturers, Inc. recalls Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and…
Recall number
Z-0283-2019
FDA classification
Class III
Brand / firm
Acumedia Manufacturers, Inc.
Sold / distributed
Worldwide distribution and US nationwide in the states of CA, GA, MN, OR, RI, TX, and WY. Countries of Canada, Mexico, Scotland, and Uruguay.

Why it was recalled

Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on distributed product listed the expiration date as November 30, 2021.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection and isolation of Listeria monocytogenes from foods and environmental samples in a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.

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