FDA recall Z-0283-2019

Acumedia Manufacturers, Inc. · Class III · device

Product

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.

Reason for recall

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.

Distribution

Worldwide distribution and US nationwide in the states of CA, GA, MN, OR, RI, TX, and WY. Countries of Canada, Mexico, Scotland, and Uruguay.

Key facts

Status
Terminated
Initiation date
2018-08-02
Report date
2018-11-07
Termination date
2020-12-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lansing, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0283-2019