Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Campylobacter Blood Free Selective Medium

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall Campylobacter Blood Free Selective Medium see related information
Date Initiated by Firm August 02, 2018
Create Date October 26, 2018
Recall Status1 Terminated 3 on January 13, 2021
Recall Number Z-0284-2019
Recall Event ID 81107
Product Classification Culture media, selective and non-differential - Product Code JSJ
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.
Code Information lot #110685B
Recalling Firm/
Manufacturer		 Acumedia Manufacturers, Inc.
740 E Shiawassee St
Lansing MI 48912-1218
For Additional Information Contact John Guenther
800-234-5333 Ext. 2362
Manufacturer Reason
for Recall		 The product is labeled with an incorrect expiration date.
FDA Determined
Cause 2		 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 in Commerce 93 bottles
Distribution US Distribution to states of: FL, TN; and internationally to countries of: Brazil, and Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-