Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1169-2007

Microlab F.A.M.E. reagent containers, Part number 148482, box containing 48 containers each. For in vitro...

Hamilton Co / initiated 2007-03-29 / Terminated

Hamilton Co began a recall of Microlab F.A.M.E. reagent containers, Part number 148482, box containing 48 containers each. For in vitro diagnostic use on . The reason FDA records is "Some product containers may be leaking". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1169-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hamilton Co
Product
Microlab F.A.M.E. reagent containers, Part number 148482, box containing 48 containers each. For in vitro diagnostic use.
Product code
JQW Station, Pipetting And Diluting, For Clinical Use
Reason for recall
Some product containers may be leaking.
FDA root cause
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.
Product codes and lots
Part number 148482, lot codes 34906, 20207, 30307, 30407, 20507, 30607, 20707, 40707.