Recall Z-0695-2016— Bio-Rad Laboratories, Inc.

Name: FDA recall Z-0695-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-15

Class II · Terminated

Class II FDA medical device recall by Bio-Rad Laboratories, Inc., initiated 2015-12-15, terminated 2016-05-02. It names one FDA 510(k) clearance: K060001. Product: 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.. Reason: 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..

Recalling firm: Bio-Rad Laboratories, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-12-15
Terminated: 2016-05-02
Firm location: Hercules, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K060001 — D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAMBio-Rad Laboratories, Inc.·cleared 2006-01-20

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 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.

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.

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