ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System.
- Company
- Diasorin Inc.
- Recall Initiated
- March 9, 2004
- Posted
- October 1, 2005
- Terminated
- July 22, 2006
- Recall Number
- Z-1576-05
- Quantity
- 128
- Firm Location
- Stillwater, MN
Reason for Recall
An error in the acceptance specification for the substrate blank optical density was discovered in the Bio-Tek ELx800 programming specifications for the ORTHO HCV Version 3.0 ELISA Test System Assay.
Distribution
AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WI & WV
Lot / Code Info
version 12 and older software
Root Cause
Other
Action Taken
Dear Customer letters, dated 03/08/2004 were sent to customers informing them of the specification error and instructing users to validate their assays manually.
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