Cl ll PhD System EIA/IFA Software

Company: Bio-Rad Laboratories, Inc.
Date of Enforcement Report 4/6/2011
Class ll:

PRODUCT
PhD System EIA/IFA Software; Model/Catalog Number: 426-0246; The Bio-Rad PhD System is an EIA and IFA processing system that consists of a PhD fluid handling station(s) linked to a network computer via an Ethernet hub. The network computer provides worklist generation, data management, data reduction and microplate reader control functions. Recall # Z-1726-2011

REASON
SFirm’s Correction involves advising customers who have implemented a Laboratory Information System (LIS) that they need to ensure quantitative results have passed all validation criteria prior to reporting patient results. When a patient result fails a Validation Rule, the qualitative result will indicate “INVALID”.

RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Inc., Hercules, CA, by letter dated January 20, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
650 units ( US 257 units and Foreign 393 units)

DISTRIBUTION
Nationwide and Internationally

About the author

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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