FDA recall Z-0284-2019

Acumedia Manufacturers, Inc. · Class III · device

Product

Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of Campylobacter spp. In a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.

Reason for recall

The product is labeled with an incorrect expiration date.

Distribution

US Distribution to states of: FL, TN; and internationally to countries of: Brazil, and Canada.

Key facts

Status
Terminated
Initiation date
2018-08-02
Report date
2018-11-07
Termination date
2021-01-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lansing, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0284-2019