Enforcement Report - Week of December 19, 2012
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Product Detail
| Product Description | Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028 Intended Use For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure. |
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| Recall Number | Z-0506-2013 |
| Classification | Class II |
| Code Info | All lot codes |
| Product Distributed Qty | 100 test=24291 and 500 test= 9679 |
| Reason For Recall | Operating range of the ADVIA Centaur systems is 18°C to 30°C (64.4°F to 86.0°F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used. |
Event Detail
| Event Id | 63682 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc |
| City | East Walpole |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-11-14 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - USA (nationwide) and Internationally to the following countries: Argentina Australia Austria Azerbaijan Belgium Bosnia Herzeg. Brazil Canada Chile COLOMBIA Croatia Czech Republic Denmark Egypt Estonia Finland France Germany Greece Hong Kong Hungary Iceland India Indonesia Iran Ireland Italy Japan Kazakhstan Latvia Lithuania Malaysia Mexico Netherlands New Caledonia Norway Oman P.R. China Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Reunion Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. United Kingdom Uruguay Vietnam |
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