Terminated

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.

FDA Recall Z-1299-2014 · Posted 2014-03-27

Recalling FirmBio-Rad Laboratories, Inc.

Recall StatusTerminated

Product CodeLCP

Date Initiated2014-02-27

Date Terminated2014-06-04

Product Quantity483 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.

Firm 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.

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031043D-10 HEMOGLOBIN A1CBio-Rad Laboratories, Inc. · 2003-08-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.