Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ.
- Company
- Zeus Scientific, Inc.
- Recall Initiated
- June 12, 2003
- Posted
- August 12, 2003
- Terminated
- February 22, 2006
- Recall Number
- Z-1095-03
- Quantity
- 270 kits
- Firm Location
- Branchburg, NJ
Reason for Recall
The Calibrator included within the kit may be losing reactivity.
Distribution
The product was distributed to 6 distributors and 24 direct accounts in the United States and Internationally. Canada; Sweden; Costa Rica; Czech; Indonesia.
Lot / Code Info
Product Number 9Z9501G Lot Number: 03022371 exp. 2004-July; 03022392 exp. 2004-July; 03022472 exp 2004-July.
Root Cause
Other
Action Taken
All customers were notified via recall letter on June 12, 2003. Letter sent out via Airborne Express. All product is to be returned to Zeus or destroyed.
More recalls by Zeus Scientific, Inc.
ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qual...
Aug 12, 2019