Recall Z-0541-2014 ยท LPS Urinary Homocystine (Nonquantitative) Test System
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
| Date | Dec 19, 2013 (initiated Sep 18, 2013) |
| Status | Terminated |
| Reason | Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples. |
| Root cause | Unknown/Undetermined by firm |
| Action | Siemens sent a Urgent Medical Device Recall letter dated September 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Actions to be taken by Customer: Please discontinue use and discard any remaining inventory of Dimension Vista HCYS Flex reagent cartridge (Catalog# K7044) lot 13064MA. Please complete the attached form and fax it to (302) 631-8467 to facilitate your no charge replacement needs. Please retain this letter with your laboratory records, and forward this letter to those who may have received this p |
| Quantity | 302 |
| Distribution | Worldwide Distribution - US Distribution including the states of OH, MD, CO, NJ, IA, NC, VA, WI and DC., and the countries of Austria, Denmark, France, Italy, Netherlands and Norway. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063206 | DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH Dade Behring, Inc., Dec 28, 2006 |