ClearanceBrief
Recall Z-1999-2009 ยท JTC Device, Microtiter Diluting/Dispensing

Hamilton Co

300 Microliter CO-RE Tips for use with Microlab STAR, manufactured by Hamilton Company, Reno, NV. Product is a disposable product used with Microlab STAR series Instruments, which are microtiter diluting and dispensing devices.

DateSep 9, 2009 (initiated Apr 9, 2009)
StatusTerminated
ReasonProduct Defect-- some tips from the mold cavity 28 are too short and do not always aspirate or dispense liquid correctly.
Root causeProcess control
ActionThe firm initiated the recall on April 10, 2009, and issued notification to consignees via certified mail and e-mail. Customers were instructed to return the affected product to the Hamilton Company. A fax-back form was supplied with each notification. Direct questions about the recall to the Hamilton Company by calling 1-775-858-3000, extension 236.
Quantity20 cases of Part 235950 and 27 cases of Part 235902.
DistributionWorldwide Distribution -- US (states of DE, NJ, PA, MA and CA), New Zealand and Japan.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.