Bio-Rad Laboratories, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1299-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 27, 2014

Date Posted: April 2, 2014

Recall Number: Z-1299-2014

Event ID: 67624

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.

Status: Terminated

Product Quantity: 483 instruments in US. OUS to be determined.

Code Information:

Model number: 220-0220

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.

Voluntary or Mandated:

Voluntary: Firm initiated