Z-0695-2016Class II

D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample...

Name: Z-0695-2016 D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample...
Creator: Bio-Rad Laboratories, Inc.
Published: 2015-12-15
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2015-12-15 / Terminated / root cause: software

FDA source

Bio-Rad Laboratories, Inc. began a recall of 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... on 2015-12-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0695-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-15
Posted: 2016-01-27
Terminated: 2016-05-02
Recalling firm: Bio-Rad Laboratories Inc.
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.
Product code: LCP Assay, Glycosylated Hemoglobin
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.
Root cause tag: software
FDA root cause: Software design
Action: Urgent Medical Device Correction letters were sent on December 2015 to all affected consignees and subsidiaries. Each subsidiary will be given a Subsidiary Medical Device Correction Notice, Customer Medical Device Correction Notice, and Return Response Form and the number of customers distributed by e-mail. Each Subsidiary much contact customers and translate the Customer Medical Device Correction Notice and Return Response Form as needed. A revised letter to subsidiaries and customers was sent on January 20, 2016.
Quantity in commerce: 165 in US, 200 Internationally
Distribution: 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.
Product codes and lots: All codes - 2006 to present

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0695-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0695-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-03	2016-01-27

Product code LCP

K060001Class IID-10 Hemoglobin A1c Program; D-10 Dual ProgramBio-Rad Laboratories, Inc. / cleared 2006-01-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)