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Terminated

ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System.

FDA Recall Z-1576-05 · Posted 2005-10-01

Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeMZO
Date Initiated2004-03-09
Date Terminated2006-07-22
Product Quantity128

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.

Firm Action

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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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