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U.S. Department of Health and Human Services

Class 3 Device Recall Acumedia Nutrient Gelatin

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  Class 3 Device Recall Acumedia Nutrient Gelatin see related information
Date Initiated by Firm March 23, 2016
Date Posted June 01, 2017
Recall Status1 Terminated 3 on June 02, 2017
Recall Number Z-2213-2017
Recall Event ID 77275
Product Classification Culture media, non-selective and non-differential - Product Code JSG
Product Nutrient Gelatin, Acumedia Part Number 7471 A

Product Usage:
Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase production. Identifying fermentative and non-fermentative Gram-negative bacilli include testing for gelatin liquefaction. If the proteolytic enzyme gelatinase is present, gelatin is hydrolyzed and loses its gelling characteristic.
Code Information PN 7471A, Lot 105550F
Recalling Firm/
Manufacturer		 Acumedia Manufacturers, Inc.
740 E Shiawassee St
Lansing MI 48912-1218
Manufacturer Reason
for Recall		 Incorrect expiration date was listed on the label. Correct expiration date was November 30, 2016. Product was labeled with expiration date of April 30, 2018.
FDA Determined
Cause 2		 Error in labeling
Action On 3/23/2016, notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, and information for the correction to product.
Quantity in Commerce 5 units
Distribution Worldwide - US Nationwide in the state of ME; in the country of ECUADOR
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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