Recall Z-2214-2017— Acumedia Manufacturers, Inc.

Class III · Terminated

Class III FDA medical device recall by Acumedia Manufacturers, Inc., initiated 2015-09-11, terminated 2017-06-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological culture media, where it is generally used to replace infusion of meat. Culture media containing Beef Extract Powder are recommended for use in bacteriological examination of water, milk, and other materials, where uniform composition of media is important. Beef Extract Powder is relied upon for biochemical studies, particularly fermentation reactions because of its independence from ferment-able substances. Several media containing Beef Extract Powder are recommended in standard methods for multiple application.. Reason: Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labeled with expiration date of March 28,2019..

Recalling firm
Acumedia Manufacturers, Inc.
Classification
Class III
Status
Terminated
Initiated
2015-09-11
Terminated
2017-06-02
Firm location
Lansing, MI, United States

Product description

Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological culture media, where it is generally used to replace infusion of meat. Culture media containing Beef Extract Powder are recommended for use in bacteriological examination of water, milk, and other materials, where uniform composition of media is important. Beef Extract Powder is relied upon for biochemical studies, particularly fermentation reactions because of its independence from ferment-able substances. Several media containing Beef Extract Powder are recommended in standard methods for multiple application.

Reason for recall

Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labeled with expiration date of March 28,2019.

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