ClearanceBrief
Recall Z-0456-05 ยท MDB System, Blood Culturing

bioMerieux

BacT/ALERT(BTA) Classic instruments.

DateFeb 1, 2005 (initiated Sep 17, 2004)
StatusTerminated
ReasonOver heating of memory board.
Root causeOther
ActionConsignees were notified by letter on September 17, 2004.
Quantity1626 units
DistributionNationwide, Argentina, Australia, Belgium, Brazil, Canada, Colombia, Denmark, Finland, France, Germany, Greece, India, Indonesia, Italy, Japan, Korea, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Thailand, Turkey, UK.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K903505BACT/ALERT (TM)
Organon Teknika Corp., Mar 12, 1991