Z-1576-05

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

Name: Z-1576-05 ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System
Creator: Diasorin Inc.
Published: 2004-03-09
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2004-03-09 / Terminated

FDA source

Diasorin Inc. began a recall of ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System on 2004-03-09. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1576-05
Status: Terminated
Initiated: 2004-03-09
Posted: 2005-10-01
Terminated: 2006-07-22
Recalling firm: Diasorin Inc.
Product: ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System.
Product code: MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
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.
FDA root cause: Other
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.
Quantity in commerce: 128
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
Product codes and lots: version 12 and older software

Product code MZO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)