ClearanceBrief
Recall Z-1169-2007 ยท JQW Station, Pipetting And Diluting, For Clinical Use

Hamilton Co

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

DateAug 16, 2007 (initiated Mar 29, 2007)
StatusTerminated
ReasonSome product containers may be leaking.
Root causeOther
ActionThe firm contacted consignees via certified mail and e-mail, initated on March 29, 2007.
Quantity797 boxes
DistributionProduct was distributed to 3 US consignees in NJ, WA and TX, with one consignee in France.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.