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U.S. Department of Health and Human Services

Class 2 Device Recall Microlab F.A.M.E. reagent containers

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  Class 2 Device Recall Microlab F.A.M.E. reagent containers see related information
Date Initiated by Firm March 29, 2007
Date Posted August 16, 2007
Recall Status1 Terminated 3 on December 21, 2007
Recall Number Z-1169-2007
Recall Event ID 38352
Product Classification reagent containers - Product Code JQW
Product Microlab F.A.M.E. reagent containers, Part number 148482, box containing 48 containers each. For in vitro diagnostic use.
Code Information Part number 148482, lot codes 34906, 20207, 30307, 30407, 20507, 30607, 20707, 40707.
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		 Some product containers may be leaking.
FDA Determined
Cause 2		 Other
Action The firm contacted consignees via certified mail and e-mail, initated on March 29, 2007.
Quantity in Commerce 797 boxes
Distribution Product was distributed to 3 US consignees in NJ, WA and TX, with one consignee in France.
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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