Z-0284-2019Class III

Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of...

Name: Z-0284-2019 Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of...
Creator: Acumedia Manufacturers, Inc.
Published: 2018-08-02
License: https://open.fda.gov/license/

Neogen Culture Media / initiated 2018-08-02 / Terminated / root cause: labeling and UDI

FDA source

Acumedia Manufacturers, Inc. began a recall of Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of Campylobacter spp. In a laboratory setting. Not... on 2018-08-02. FDA classified it as Class III and gives the reason as "The product is labeled with an incorrect expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0284-2019
Classification: Class III
Status: Terminated
Initiated: 2018-08-02
Posted: 2018-10-26
Terminated: 2021-01-13
Recalling firm: Neogen Culture Media
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.
Product code: JSJ Culture Media, Selective And Non-Differential
Reason for recall: The product is labeled with an incorrect expiration date.
Root cause tag: labeling and UDI
FDA 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: [email protected].
Quantity in commerce: 93 bottles
Distribution: US Distribution to states of: FL, TN; and internationally to countries of: Brazil, and Canada.
Product codes and lots: lot #110685B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0284-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0284-2019	Class III	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-26

Product code JSJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)