Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0718-2008

Hamilton Sample Carriers for the ML STAR line (SMP-CAR-24)

Hamilton Co / initiated 2007-06-25 / Terminated / root cause: labeling and UDI

Hamilton Co began a recall of 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... on . The reason FDA records is "Incorrectly 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". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0718-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hamilton Co
Product
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.)
Product code
JTC Device, Microtiter Diluting/Dispensing
Reason for recall
Incorrectly 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 cause tag
labeling and UDI
FDA root cause
Error in labeling
Action
The 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.
Quantity in commerce
179 units distributed.
Distribution
Worldwide Distribution --- USA including states of OH, CA, NJ, NC, and countries of Japan, France, Switzerland, Spain, Italy, Germany, and the UK.
Product codes and lots
Serial Numbers: S0213281 to S0214480.