Recall Z-1299-2014— Bio-Rad Laboratories, Inc.

Name: FDA recall Z-1299-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-27

Class II · Terminated

Class II FDA medical device recall by Bio-Rad Laboratories, Inc., initiated 2014-02-27, terminated 2014-06-04. It names one FDA 510(k) clearance: K031043. Product: 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.. Reason: 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..

Recalling firm: Bio-Rad Laboratories, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-02-27
Terminated: 2014-06-04
Firm location: Hercules, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K031043 — D-10 HEMOGLOBIN A1CBio-Rad Laboratories, Inc.·cleared 2003-08-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.