Bio-Rad Laboratories, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0695-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

D-10 Rack Loader; Model Number 220-0600; Hematology: 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: December 15, 2015

Date Posted: February 3, 2016

Recall Number: Z-0695-2016

Event ID: 72927

Reason for Recall:

On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration.

Status: Terminated

Product Quantity: 165 in US, 200 Internationally

Code Information:

All codes - 2006 to present

Distribution Pattern:

Worldwide Distribution-US (nationwide) and the countries of Canada, Australia, Belgium, Brazil, Brunei Darussalam, China, Czech Republic, France, Germany, Greece, India, Israel, Italy, Malaysia, Maldives, New Zealand, Norway, Austria, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Thailand, and UK.

Voluntary or Mandated:

Voluntary: Firm initiated