Oct

2005

Diasorin Inc. Class III

Company: Datascope Corp.
Date of Enforcement Report: 10/5/2005
Class:III

PRODUCT
Elx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System. Recall # Z-1576-05

REASON
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.

CODE
Version 12 and older software

RECALLING FIRM/MANUFACTURER
Recalling Firm: Diasorin Inc., Stillwater, MN, by letters dated March 8, 2004.
Manufacturer: Ortho Clinical Diagnostics, Inc., Raritan, NJ. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
128

DISTRIBUTION
Nationwide

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Diasorin Inc. Class III

Amy Sellers

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