ClearanceBrief
Recall Z-0928-03 ยท KTO Reagent, Immunoassay, Igg

Ventana Medical Systems Inc

iVIEW DAB Detecion Kit. Catalog Number 760-091

DateJun 17, 2003 (initiated May 7, 2003)
StatusTerminated
ReasonKit does not stain tissues properly.
Root causeOther
ActionRecall notification was made by telephone on May 6 and 7, 2003. A faxed letter and response form followed.
Quantity409 kits
DistributionNationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.