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U.S. Department of Health and Human Services

Class 2 Device Recall HardyCHROM VRE Agar

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  Class 2 Device Recall HardyCHROM VRE Agar see related information
Date Initiated by Firm June 24, 2015
Date Posted July 22, 2015
Recall Status1 Terminated 3 on August 28, 2015
Recall Number Z-2192-2015
Recall Event ID 71577
Product Classification Culture media, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
Product HardyCHROM VRE Agar-RSR

Cat no: GA333 Lot no: H15055
Expires: 2015-07-04
Container type: 15x100mm monoplate
Packaged: 10 plates/sleeve
Storage 2 to 8 degrees C on receipt

Chromogenic medium for stool pathogen screening.
Code Information Cat No.: G333 Lot No.: H15055
Recalling Firm/
Hardy Diagnostics
1430 W Mccoy Ln
Santa Maria CA 93455-1005
For Additional Information Contact
800-266-2222 Ext. 5674
Manufacturer Reason
for Recall
Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.
FDA Determined
Cause 2
No Marketing Application
Action The firm initially called customers to inform them of the recall. The firm's phone script stated that they were discontinuing the product and as part of the process were recalling anything that still might be within expiration date. The phone script stated that the firm was going to be sending something in writing. On 06/24/15 the firm sent out a notification letters to customers to inform them that they were discontinuing the product, and were requested anything remaining within expiration to be discarded. The firm requests that customers complete, sign, and fax back the enclosed form stating their compliance with the above action. For any questions the firm states to contact Technical Services Department at 800-266-222, option 2 or via email at TechService@HardyDiagnostics.com.
Quantity in Commerce 1,500
Distribution Distributed to one U.S. customer in SC.
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.