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U.S. Department of Health and Human Services

Class 2 Device Recall ML STAR Sample Carriers

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  Class 2 Device Recall ML STAR Sample Carriers see related information
Date Initiated by Firm June 25, 2007
Date Posted February 08, 2008
Recall Status1 Terminated 3 on April 15, 2008
Recall Number Z-0718-2008
Recall Event ID 38335
Product Classification Microtiter diluting/dispensing device - Product Code JTC
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.)
Code Information Serial Numbers: S0213281 to S0214480.
Recalling Firm/
Manufacturer		 Hamilton Co
4970 Energy Way
Reno NV 89502-4123
For Additional Information Contact
775-858-3000 Ext. 236
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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