Recall Z-0253-2013 ยท LPS Urinary Homocystine (Nonquantitative) Test System
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
| Date | Nov 6, 2012 (initiated Aug 3, 2012) |
| Status | Terminated |
| Reason | Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge. |
| Root cause | Packaging |
| Action | Siemens sent a Urgent Field Safety Notice letter dated July 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. At this time Siemens Healthcare Diagnostics is conducting a voluntary recall for Dimension Vista HCYS Flex reagent cartridge lots 12062MA and 12066MA. Please immediately discontinue use and discard any remaining inventory of Dimension Vista HCYS (K7044) lots 12062MA and 12066MA. Please complete the attached form and fax it to (302)631-8467 to indicate that you have received this information. We ask |
| Quantity | 583 cartons |
| Distribution | USA (nationwide) including the states of AL, CA, CO, CT, DC, DE, FL, IA, IL, IN, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA and WI. |
| 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 |