Recall Z-0695-2016 ยท LCP Assay, Glycosylated Hemoglobin
Bio-Rad Laboratories, Inc.
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.
| Date | Jan 27, 2016 (initiated Dec 15, 2015) |
| Status | Terminated |
| 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. |
| 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 | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060001 | D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM Bio-Rad Laboratories, Inc., Jan 20, 2006 |