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U.S. Department of Health and Human Services

Class 2 Device Recall IMMULITE /IMMULITE 1000 Folic Acid

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 Class 2 Recall
IMMULITE /IMMULITE 1000 Folic Acid
see related information
Date Posted December 24, 2013
Recall Status1 Open
Recall Number Z-0569-2014
Recall Event ID 66713
Premarket Notification
510(K) Number
K943705 
Product Classification Acid, Folic, Radioimmunoassay - Product Code CGN
Product 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.
Code Information Kit Lots 335, 336, and 337
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics
511 Benedict Ave
Tarrytown, New York 10591-5005
Manufacturer 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.
Action Siemens sent an Urgent Medical Device Correction notices dated November 7 2013, via FedEx to the US customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers are instructed that If the adjustment slope is less than or equal to 1.8 and quality control results are within the established ranges, the kit may be used to generate patient results. If the adjustment slope is greater than 1.8, customers are instructed to discontinue use and discard the kit lots. Ex-US distribution is determined at the country level. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within thirty (30) days. Field service personnel were sent a support document describing the issue and instructing them how to deal with customer questions. For further questions please call CUSTOMER CARE CENTER NUMBER: (302) 631-7597.
Quantity in Commerce Domestic: 442 kits; Foreign: 680 kits
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
510(K) Database 510(K)s with Product Code = CGN and Original Applicant = DIAGNOSTIC PRODUCTS CORP.
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