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U.S. Department of Health and Human Services

Class 3 Device Recall Acumedia Urea Base Agar

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  Class 3 Device Recall Acumedia Urea Base Agar see related information
Date Initiated by Firm September 25, 2016
Create Date June 02, 2017
Recall Status1 Terminated 3 on June 02, 2017
Recall Number Z-2221-2017
Recall Event ID 77276
Product Classification Culture media, selective and differential - Product Code JSI
Product Urea Base Agar, Acumedia PN 7226
Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
Code Information PN 7226A, Lot 108812A PN 7226B, Lot 108812A PN 7226A, Lot 107 699C
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		 Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C.
FDA Determined
Cause 2		 Error in labeling
Action Neogen Corporation sent a Product Notification dated September 25, 2016, to all affected consignees via email. The recall notification included a description of the reason for the recall, affected product, and information for the correction to product. Consignees were informed that an internal corrective action has been initiated and actions have been taken and implemented to prevent this situation from occurring again. The label has been corrected and existing inventory has been relabeled. For questions regarding this recall call 800-234-5333, ext 2362.
Quantity in Commerce 28 units
Distribution Worldwide Distribution - US to AZ; Internationally to ECUADOR; CANADA; UK; BRAZIL
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.
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