Class 3 Device Recall PhD System EIA/IFAversion 2.1A software

• Date Initiated by Firm: September 29, 2009
• Date Posted: March 02, 2011
• Recall Status: Terminated on March 11, 2011
• Recall Number: Z-1495-2011
• Recall Event ID: 53690
• Product Classification: Station, pipeting and diluting for clinical use - Product Code JQW
• Product: PhD System EIA/IFAversion 2.1A software, model number 426-0246, a component of the Bio-Rad PhD System. Manufactured by Bio-Rad Laboratories, France, Distributed by Bio-Rad Laboratories, Hercules, CA. 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 worklist generation, data management, data reduction and microplate reader control functions.
• Code Information: Model 426-0246, software version 2.1A
• Recalling Firm/ Manufacturer: Bio-Rad Laboratories Inc; 4000 Alfred Nobel Dr; Hercules CA 94547-1803
• For Additional Information Contact: Jolene Bartilson; 510-724-7000
• Manufacturer Reason for Recall: Incorrect patient results are being generated from out-of-range samples tested withc ompetitive enzyme immunoassays on the PhD system with software version 2.1A.
• FDA Determined Cause: Software change control
• Action: BIO-RAD sent an URGENT: MEDICAL DEVICE CORRECTION letter dated September 29, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their customer records to identify all PhD System customers that are using version 2.1A of the EIA/IFA Software and Methods CD-ROM. Customers who are not running competitive immunoassays on the PhD System may continue using the 2.1A software. Customers who run competitive immunoassays must revert to software version 2.0B. Customers were instructed to translate if necessary and add local contact information to the customer letter and distribute to all PhD System customers that are using 2.1A of the EIA/IFA Software and Methods CD-ROM. A Customer Medical Device Correction Response Form must be collected from each customer to ensure that they have received this important communication. Once forms have been collected from all applicable customers, they should be faxed to Bio-Rad CSD Regulatory Affairs Department along with the completed Subsidiary Medical Device Correction Response Form. For questions regarding this recall call 510-741-3954.
• Quantity in Commerce: 262 units
• Distribution: Worldwide Distribution - USA including AL, CA, CO, CT, DC, FL, IL, MA, MD, MN, MO, MS, MT, NC, NY, OH, PA, SD, TN, TX, UT, and VT and the countries of Australia, New Zealand, Singapore, China, France, Sweden, and Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.