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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 Recall
Microlab F.A.M.E. reagent containers
see related information
Date Posted August 16, 2007
Recall Status1 Terminated on December 21, 2007
Recall Number Z-1169-2007
Recall Event ID 38352
Product Classification Station, Pipetting And Diluting, For Clinical Use - 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, Nevada 89502-4123
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Some product containers may be leaking.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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