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U.S. Department of Health and Human Services

Class 2 Device Recall PhD System EIA/IFA Software

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 Class 2 Recall
PhD System EIA/IFA Software
see related information
Date Posted March 18, 2011
Recall Status1 Terminated on August 17, 2011
Recall Number Z-1726-2011
Recall Event ID 57778
Product Classification Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
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. Product is manufactured by Bio-Rad Laboratories, Inc., Espace European De L Enterprise Strasbourg Schiltigheim, FRANCE
Code Information All versions.
Recalling Firm/
Manufacturer
Bio-Rad Laboratories, Inc.
4000 Alfred Nobel Dr
Hercules, California 94547-1803
Consumer Instructions No consumer action necessary
For Additional Information Contact Praful Deshmane
510-724-7000
Manufacturer Reason
for Recall
Firm'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".
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action The firm, Bio-Rad, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated January 20, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the PhD Worklist Results to verify that all validations have passed and that the quantitative results are valid; to translate (if necessary) the customer letter, add local contacts information, distribute to all active PhD System customers in their region and provide tracking documentation to CSD-RA for all customers who received the customer letter. If you have any questions, contact the Bio-Rad CSD Regulatory Affairs Department at (510) 741-4618.
Quantity in Commerce 650 units
Distribution Worldwide distribution: USA and countries including:Canada, China, Australia, New Zealand, Czech Republic, France, Hong Kong, India, Italy, Korea, Singapore, Sweden, Taiwan and United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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