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
