Diasorin Inc. ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System.
Brand
Diasorin Inc.
Lot Codes / Batch Numbers
version 12 and older software
Products Sold
version 12 and older software
Diasorin Inc. is recalling ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Tes due to An error in the acceptance specification for the substrate blank optical density was discovered in the Bio-Tek ELx800 programming specifications for t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, KS, LA, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NY, NC, OH, OR, PA, TN, TX, UT, VA, WV, WI, DC
Page updated: Jan 10, 2026