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U.S. Department of Health and Human Services

Class 2 Device Recall Microlab AT, Microlab AT, Microlab AT2

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  Class 2 Device Recall Microlab AT, Microlab AT, Microlab AT2 see related information
Date Initiated by Firm December 13, 2005
Date Posted February 14, 2006
Recall Status1 Terminated 3 on May 07, 2008
Recall Number Z-0514-06
Recall Event ID 34324
510(K)Number K871945  
Product Classification Device, Microtiter Diluting/Dispensing - Product Code JTC
Product Microlab AT, part numbers 135001, 135001OOC, 135002, 135003, 135005, 135006, 135006R, 135007, 135008, 135016, 135028, 135029, 936400, 936400BLU.

Microlab AT+ and Microlab AT+2, part numbers 142000, 142001, 142001R, 142002, 142003, 142005, 142006, 142006R, 142007, 142008, 142009, 142015, 142017, 142035, 142036
Code Information All codes included.
Recalling Firm/
Manufacturer		 Hamilton Co
4970 Energy Way
Reno NV 89502-4123
For Additional Information Contact Wayne McAuliffe
775-858-3000
Manufacturer Reason
for Recall		 Heat sinking on power boards may not operate as intended and the board may cease to operate.
FDA Determined
Cause 2		 Other
Action On 12/15/05, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.
Quantity in Commerce 1071 units
Distribution Product was released for distribution to 132 consignees in US, and 17 International consignees
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 = JTC and Original Applicant = HAMILTON CO.
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