Recall Z-1869-2012 ยท CDD Radioassay, Vitamin B12
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma.
| Date | Jun 27, 2012 (initiated May 8, 2012) |
| Status | Terminated |
| Reason | Siemens Healthcare Diagnostics has confirmed that the presence of Intrinsic Factor Blocking Antibody in some patients can result in a false and significant elevation in the reported concentration of Vitamin B12 on the Dimension Vista System. This issue affects all lots of B12 Flex reagent cartridges on the Dimension Vista System. |
| Root cause | Device Design |
| Action | Siemens Healthcare Diagnostics Inc. sent a Urgent Device Recall letter to all affected customers dated May 2012. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed customers to immediately discontinue use of the device, quarantine and dispose of all inventory, ensure that your Medical Director reviews this letter as well as the attached physician letter. Please complete the attached Field Correction form and fax to 302-631-8467. Further questions please call 302-631-6311. |
| Quantity | 59,735 |
| Distribution | Worldwide Distribution -- USA (nationwide) and the countries of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Great Britian, Italy, Netherlands, Norway, Portugal, Slovakia, South Africa, Spain, Switzerland, United Arab Emirates, Canada, New Zealand, and South Korea. *** Cen |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071224 | DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR Dade Behring, Inc., Nov 13, 2007 |