Class 2 Device Recall D10" Hemoglobin Testing System

• Date Initiated by Firm: February 27, 2014
• Date Posted: March 27, 2014
• Recall Status: Terminated on June 04, 2014
• Recall Number: Z-1299-2014
• Recall Event ID: 67624
• 510(K)Number: K031043
• Product Classification: Assay, glycosylated hemoglobin - Product Code LCP
• Product: D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection and analysis.
• Code Information: Model number: 220-0220
• Recalling Firm/ Manufacturer: Bio-Rad Laboratories, Inc.; 4000 Alfred Nobel Dr; Hercules CA 94547-1803
• For Additional Information Contact: Nishi Singh; 510-741-6114
• Manufacturer Reason for Recall: On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Bio-Rad Laboratories, Inc. sent an Urgent Medical Device correction letter dated February 27, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A Customer medical Device Correction Response Form must be collected from each customer to ensure that they have received this communication. Forms should be faxed to the Bio-Rad CSD Regulatory Affairs Department at 510-741-3954 along with the completed Subsidiary Medical Device Correction Response Form. For questions regarding this recall call 570-741-6114.
• Quantity in Commerce: 483 instruments in US. OUS to be determined.
• Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada, Japan, China, India, SriLanka, Argentina, Paraguay, Uruguay, Chile, Peru ,Bolivia ,Mexico ,Panama, ,Costa Rica ,Ecuador, Venezuela, Colombia, Brazil, Jamaica, Austria, Switzerland, France, Germany, Greece, Portugal, Spain, Italy, UK, Belgium, Sweden Norway, Finland ,Israel/Palestine, Tunisia, Algeria, Egypt, ,Morocco, Jordan, Yemen, Iraq, Kuwait, Qatar, Oman, Lybia, Lebanon ,UAE, Saudi Arabia, Pakistan, Afghanistan, Turkey, South Africa, Chad, Kenya, Benin, Burkina Faso, Cameroon, Gabon, Senegal, Ghana, Mali, Ivory Coast, Nigeria, Djibouti, Czech Republic, Slovakia, Slovenia, Serbia, Hungary, Romania, Poland, Russia, Ukraine, Kazakhstan, Bulgaria, Belarus, Georgia, Mauritius, Maldives, Vietnam, Philippines, Korea, Thailand, Hong Kong , Indonesia, Taiwan, Malaysia, Singapore, New Zealand, and Australia.
• 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.

• 510(K) Database: 510(K)s with Product Code = LCP