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U.S. Department of Health and Human Services

Enforcement Report - Week of April 2, 2014

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Product Detail

Product Description 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.
Recall Number Z-1299-2014
Classification Class II
Code Info Model number: 220-0220
Product Distributed Qty 483 instruments in US. OUS to be determined.
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.

Event Detail

Event Id 67624
Product Type Devices
Status Ongoing
Recalling Firm Bio-Rad Laboratories, Inc.
City Hercules
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-27
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.