Enforcement Report - Week of November 14, 2012
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-0253-2013 |
| Classification | Class III |
| Code Info | Lot numbers 12062MA, exp 12/01/2012; and 12066MA, exp 12/05/2012 |
| Product Distributed Qty | 583 cartons |
| Reason For Recall | Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge. |
Event Detail
| Event Id | 62833 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| City | Newark |
| State | DE | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-03 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | 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. |
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