FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0284-2019
- Recalling firm
- Acumedia Manufacturers, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2018-08-02
- Posted
- not on file
- Terminated
- 2021-01-13
- 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.
- Lot, serial or model codes
- lot #110685B
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSJ
- Firm FEI
- 1120041
- Firm city
- Lansing
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28