ClearanceBrief
Recall Z-1203-2009 ยท JTC Device, Microtiter Diluting/Dispensing

Hamilton Co

300 microliter CO-RE tips for use with Microlab STAR series instruments, Part Number 235902, 5,760 tips per case, manufactured by Hamilton Company, Reno, NV. The products are a disposable product that are used with the Microlab STAR series instruments, which are microtiter diluting and dispensing devices.

DateApr 17, 2009 (initiated Dec 1, 2008)
StatusTerminated
ReasonSome tips may be occluded and are unable to aspirate or dispense liquid.
Root causeProcess control
ActionAn "Urgent: Product Recall Letter" dated December 1, 2008 was issued to consignees via certified mail and e-mail. The letter described the problem and potential effects of use. Consignees were instructed to complete the enclosed "Hamilton Company Product Recall Questionnaire" and return it via e-mail or fax (775-856-7259) to the Hamilton Company. After receipt of the completed questionnaire, the firm's Customer Service Department will contact consignees to provide Returned Material Authorization information for returning affected product. Direct questions to the Hamilton Company at 775-85
Quantity28 cases
DistributionNationwide Distribution -- MA, CA, MN, CT, and NC.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.