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.)
| Date | Feb 8, 2008 (initiated Jun 25, 2007) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.