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U.S. Department of Health and Human Services

Enforcement Report - Week of December 19, 2012

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Product Detail

Product Description Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 Ref Kit (US only) 00203473 Intended Use For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems.
Recall Number Z-0511-2013
Classification Class II
Code Info Al lot codes
Product Distributed Qty 100 Test=27392; 500 test=21045 and Reference Kits=3773
Reason For Recall Operating range of the ADVIA Centaur systems is 18C° 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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