FDAFDA · Food and drugs·Recall number Z-1299-2014
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.
Published April 2, 2014 · Recall initiated: February 27, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bio-Rad Laboratories, Inc.
- Distributor
- 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.
- Lot
- Model number: 220-0220
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.