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