Recall Z-0284-2019 ยท JSJ Culture Media, Selective And Non-Differential
Acumedia Manufacturers, Inc.
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.
| Date | Aug 2, 2018 |
| Status | Terminated |
| Reason | The product is labeled with an incorrect expiration date. |
| Root cause | Error in labeling |
| 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: mratliff@neogen.com. |
| Quantity | 93 bottles |
| Distribution | US Distribution to states of: FL, TN; and internationally to countries of: Brazil, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.