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U.S. Department of Health and Human Services

Class 3 Device Recall HardyCHROM 0157

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  Class 3 Device Recall HardyCHROM 0157 see related information
Date Initiated by Firm August 21, 2006
Date Posted October 27, 2006
Recall Status1 Terminated 3 on June 14, 2011
Recall Number Z-0078-2007
Recall Event ID 36309
Product Classification E coli 0157 testing - Product Code GMZ
Product HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates per sleeve, Hardy Diagnostics, Santa Maria, CA 93455
Code Information Lot numbers: 06192 (exp: 10/09/2006) and 06235 (exp:10/22/2006)
Recalling Firm/
Manufacturer
Hardy Media Inc Dba Hardy Diag
1430 W Mccoy Ln
Santa Maria CA 93455-1005
For Additional Information Contact Kelley J. Day
800-266-2222 Ext. 5695
Manufacturer Reason
for Recall
Performance failure; the product is failing to show pigment development for E. coli 0157.
FDA Determined
Cause 2
Other
Action Customers were first notified by phone on 8/21/06. Then all customers are faxed and mailed a signed recall letter via first class mail. All customers will be contacted, calling every few days until all have responded and all product reconciliation is made. A second recall notice was mailed 09/25/06 to include the original lot (#06192) plus an additional lot (#06235). Customers will be instructed to dispose of all remaining inventory. Hardy Diagnostics will credit or replace their purchase.
Quantity in Commerce 850 plates
Distribution Nationwide Distribution, including the states of CA, IL, ME, NV, OK, TX, UT, WA & WY
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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