ClearanceBrief
Recall Z-0718-2008 ยท JTC Device, Microtiter Diluting/Dispensing

Hamilton Co

Hamilton Sample Carriers for the ML STAR line (SMP-CAR-24). Product Code: 866.2500; Part Number: 173400. Hamilton Company, Reno, NV 89520 (Accessory on the Microlab STAR series instruments.)

DateFeb 8, 2008 (initiated Jun 25, 2007)
StatusTerminated
ReasonIncorrectly labeled-- Product has the wrong barcode labeling. The barcode error will not influence the results of testing. The instrument will discover the error and post an error notice.
Root causeError in labeling
ActionThe firm sent an Urgent: Product Recall letter to consignees on June 25, 2007. The firm also issued an alert via their User news distribution. They instructed consignees to examine their stock and return any affected carriers. A fax back form was supplied with the notification. The firm will be providing replacements.
Quantity179 units distributed.
DistributionWorldwide Distribution --- USA including states of OH, CA, NJ, NC, and countries of Japan, France, Switzerland, Spain, Italy, Germany, and the UK.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.