ClearanceBrief
Recall Z-0032-06 ยท JPA System, Multipurpose For In Vitro Coagulation Studies

BIOMERIEUX, INC.

VeriCal Calibrator Set

DateOct 22, 2005 (initiated Aug 19, 2005)
StatusTerminated
ReasonThe product is being recalled due to mis-assignment of ISI values associated with VeriCal use.
Root causeOther
ActionConsignees were notified on/about 08/31/2005.
Quantity2334 kits
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.