Jun

2011

Cl ll BIO-RAD EVOLIS System Software CD

Company:Bio-Rad Laboratories
Date of Enforcement Report 6/1/2011
Class ll:

PRODUCT
Software CD is labeled in part: “BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***” The EVOLIS Assay Protocol Files (APF) Software contains assay-specific instructions necessary for the EVOLIS Microplate processing system to process enzyme immunoassays on the EVOLIS instrument, perform data reduction and generate reports. Recall # Z-2201-2011

REASON
The EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative sample values..

RECALLING FIRM/MANUFACTURER
Recalling Firm: Bio-Rad Laboratories, Redmond, WA, by letter dated July 19, 2010, via FedEx.
Manufacturer: Bio Rad Laboratories, Marnes La Coquette, France. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
272 units

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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Cl ll BIO-RAD EVOLIS System Software CD

Amy Sellers

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