FDA Recall Terminated

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.

Recall: Z-0284-2019 · Initiated August 2, 2018

Recall

Recall Number
Z-0284-2019
Event Number
81107
Firm
Acumedia Manufacturers, Inc.
FEI Number
1120041
Product Code
JSJ
Status
Terminated
Root Cause
Error in labeling
Initiated
August 2, 2018
Terminated
January 13, 2021
Address
740 E Shiawassee St, Lansing, MI, 48912-1218

Description

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

The product is labeled with an incorrect expiration date.

Action

The firm, Neogen, sent a "Product Notification" letter dated 8/2/2018 to customers on 8/2/2018. The letter described the product, problem and actions to be taken. The customers were instructed to amend the dating on the labeling accordingly and include the notification with the bottle(s). If you have any questions, contact the Senior Director of Quality Systems at 800-234-5333 Ext3230 or email: [email protected].

Distribution

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

Quantity

93 bottles