Z-1299-2014Class II

D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000...

Name: Z-1299-2014 D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000...
Creator: Bio-Rad Laboratories, Inc.
Published: 2014-02-27
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2014-02-27 / Terminated / root cause: manufacturing process

FDA source

Bio-Rad Laboratories, Inc. began a recall of 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... on 2014-02-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1299-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-27
Posted: 2014-03-27
Terminated: 2014-06-04
Recalling firm: Bio-Rad Laboratories Inc.
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.
Product code: LCP Assay, Glycosylated Hemoglobin
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 483 instruments in US. OUS to be determined.
Distribution: 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.
Product codes and lots: Model number: 220-0220

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1299-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1299-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-26

Product code LCP

K031043Class IID-10 Hemoglobin A1cBio-Rad Laboratories, Inc. / cleared 2003-08-27

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)