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U.S. Department of Health and Human Services

Class 2 Device Recall HardyCHROM MRSA

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  Class 2 Device Recall HardyCHROM MRSA see related information
Date Initiated by Firm July 09, 2015
Date Posted August 26, 2015
Recall Status1 Terminated 3 on November 10, 2015
Recall Number Z-2463-2015
Recall Event ID 71804
510(K)Number K102922  
Product Classification Culture media, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
Product HardyCHROM MRSA
Cat no: G307 Lot no: H15155
Expires: 2015-08-13
Container Type: 15x100mm monoplate
Packaged: 10 plates/sleeve
Storage: 2-8C on receipt. Light Sensitive.

In vitro diagnostic
www.HardyDiagnostics.com
Code Information Cat no. G307 Lot no. H15155
Recalling Firm/
Manufacturer		 Hardy Diagnostics
1430 W Mccoy Ln
Santa Maria CA 93455-1005
For Additional Information Contact Technical Services Department
800-266-2222 Ext. 2
Manufacturer Reason
for Recall		 Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action The firm initially notified customers via phone to inform them of a recall. The phone scripts asks customers if they have had any issued with the QC testing. The firm states that our of a precaution they are asking customers to discard the remaining plates of the identified lot, and that credit or replacement plates will be offered for any remaining. The firm followed-up phone calls with a written notification letter. The letter states to complete, sign, and fax or email back the enclosed form stating compliance with the above action. The letters states that is the customer could not be reached via phone and would like replacements or credit to contact the Customer Service Department at 800-266-2222, option 1. Any questions call the Technical Services Department at 800-266-2222, option 2 or email at techservice@hardy diagnostics.com.
Quantity in Commerce 2,820 (282 pk/10)
Distribution Distributed in the states of VA, PA, NY, NJ, IL, OH, and MD.
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.
510(K) Database 510(K)s with Product Code = JSO and Original Applicant = HARDY DIAGNOSTICS
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