ClearanceBrief
Recall Z-0471-06 ยท JAC System, X-Ray, Film Marking, Radiographic

AGFA Corp.

Agfa Cronex 10T Radiographic film

DateFeb 4, 2006 (initiated Dec 21, 2005)
StatusTerminated
ReasonMislabeling; Product labeled Cronex 10T actually contains Afga, Curix Ultra UVL Plus.
Root causeOther
ActionConsignees were first contact by telephone followed up with a certified letter, on/about 12/21/2005.
Quantity118 boxes
DistributionAZ, CA, CO, GA, IL, MI, NE, NV, OH, OR, WA and Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.