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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Product Detail

Product Description IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- Siemens Healthcare Diagnostics Products Ltd. An IVD for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.
Recall Number Z-0569-2014
Classification Class II
Code Info Kit Lots 335, 336, and 337
Product Distributed Qty Domestic: 442 kits; Foreign: 680 kits
Reason For Recall potential for an accelerated decline in counts per second (CPS) for three IMMULITE/IMMULITE 1000 Folic Acid kit lots. This may lead to a failed adjustment before the labeled expiration date is reached.

Event Detail

Event Id 66713
Product Type Devices
Status Ongoing
Recalling Firm Siemens Healthcare Diagnostics
City Tarrytown
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of Argentina, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Denmark, Dominican Republic, Estonia, France, Germany, Great Britain, Greece, Guatemala, Hungary, India, Italy, Latvia, Mexico, Netherlands, Panama, Paraguay, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Tunisia, United Arab Emirates, Uzbekistan and Venezuela.