Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1451-06

BHI Agar with Vancomycin, for in vitro diagnostic use. Catalog # G14, Lot# 06136

Hardy Diagnostics / initiated 2006-06-27 / Terminated

Hardy Media Inc Dba Hardy Diag began a recall of BHI Agar with Vancomycin, for in vitro diagnostic use. Catalog # G14, Lot# 06136 on . The reason FDA records is "This recall is being conducted due to the performance failure nearing the end of the product shelf life". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1451-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hardy Diagnostics
Product
BHI Agar with Vancomycin, for in vitro diagnostic use. Catalog # G14, Lot# 06136
Product code
JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Reason for recall
This recall is being conducted due to the performance failure nearing the end of the product shelf life.
FDA root cause
Other
Action
Customers were first notified by phone on 6/28/06, then all customers were faxed and mailed a signed recall letter via first class mail.
Quantity in commerce
860 plates
Distribution
Nationwide in AZ, CA, IA, ID, MI, MT, NC, & WY. Plus: Puerto Rico
Product codes and lots
Lot# 06136