Recall Z-1299-2014 ยท LCP Assay, Glycosylated Hemoglobin
Bio-Rad Laboratories, Inc.
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 re
| Date | Mar 27, 2014 (initiated Feb 27, 2014) |
| Status | Terminated |
| 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. |
| 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 | 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, Ital |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031043 | D-10 HEMOGLOBIN A1C Bio-Rad Laboratories, Inc., Aug 27, 2003 |