Class 3 Device Recall Acumedia Sabouraud Dextrose Agar w /Lecithin and Tween 20

• Date Initiated by Firm: August 08, 2016
• Date Posted: June 01, 2017
• Recall Status: Terminated on June 02, 2017
• Recall Number: Z-2212-2017
• Recall Event ID: 77281
• Product Classification: Culture media, non-selective and non-differential - Product Code JSG
• Product: Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds
• Code Information: PN 91081C, Lot 108367A PN 91081C, Lot 107632A
• 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 2-30C. Actual storage temperature is 2-8C.
• FDA Determined Cause: Error in labeling
• Action: On 8/8/2016 and 10/6/2016, 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: 10 units
• Distribution: US in the state of IL
• 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.