Mar

2011

Cl ll PhD System EIA/IFAversion 2.1A software

Company: Bio-Rad Laboratories Inc.
Date of Enforcement Report 3/9/2011
Class ll:

PRODUCT
PhD System EIA/IFAversion 2.1A software, model number 426-0246, a component of the Bio-Rad PhD System. EIA and IFA processing system that consists of a PhD fluid handling station (s) linked to a network computer via Ethernet hub. The computer provides work list generation, data management, data reduction and microplate reader control functions. Recall # Z-1495-2011

REASON
Incorrect patient results are being generated from out-of-range samples tested with competitive enzyme immunoassays on the PhD system with software version 2.1A.

RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories Inc., Hercules, CA, by letter dated September 29, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
262 units

DISTRIBUTION
Nationwide, Australia, New Zealand, Singapore, China, France, Sweden, and Canada

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 PhD System EIA/IFAversion 2.1A software

Amy Sellers

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