Recall Z-1268-2012 ยท MRG System, Test, Vitamin D
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Vitamin D Diluent 2-pack, Reference 10494100 in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium-heparin, sodium heparin) using the ADVIA Centaur and ADVIA Centaur XP systems The ADVIA Centaur Vitamin D Total (Vit D) assay is for in vitro diagnostic use in the quantitative determination of total 25 (OH
| Date | Mar 21, 2012 (initiated Feb 16, 2012) |
| Status | Terminated |
| Reason | Automatic and system-performed dilution calculation factor for Vitamin D dilutions is incorrect and causes diluted patient samples to under recover by approximately 50%. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Siemens Healthcare Diagnostics, sent an "Urgent Device Recall Notice" on February 16, 2012 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to discontinue using the automatic and system-performed dilution features for Vitamin D; to discontinue the use of ADVIA Centaur VitD Diluent, 2-pack (REF 10494100); to manually dilute samples with values greater than the assay range of 150 ng/mL (375 nmoI/L), using the ADVIA Centaur VitD Diluent, 1 bottle (REF 10632114) as stated in the Vitamin D assay Instructions For Use (IFU) |
| Quantity | 442 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Columbia, China, Denmark, Egypt, and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110586 | ADVIA CENTAUR VITAMIN D TOTAL ASSAY Siemens Healthcare Diagnostics, Inc., Oct 14, 2011 |