Medical device recalls

Acumedia Manufacturers, Inc. recalls Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from…

Recall date
August 8, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2212-2017
FDA classification
Class III
Brand / firm
Acumedia Manufacturers, Inc.
Sold / distributed
US in the state of IL

Why it was recalled

Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C.

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

What was recalled

Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds

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