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

• Date Initiated by Firm: December 13, 2005
• Date Posted: February 14, 2006
• Recall Status: Terminated 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.
• FEI Number: 2915796
• 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: 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