Medical device recalls

Acumedia Manufacturers, Inc. recalls Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microo…

Recall date
March 23, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2213-2017
FDA classification
Class III
Brand / firm
Acumedia Manufacturers, Inc.
Sold / distributed
Worldwide - US Nationwide in the state of ME; in the country of ECUADOR

Why it was recalled

Incorrect expiration date was listed on the label. Correct expiration date was November 30, 2016. Product was labeled with expiration date of April 30, 2018.

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

What was recalled

Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase production. Identifying fermentative and non-fermentative Gram-negative bacilli include testing for gelatin liquefaction. If the proteolytic enzyme gelatinase is present, gelatin is hydrolyzed and loses its gelling characteristic.

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