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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 Device Recall IMMULITE /IMMULITE 1000 Folic Acid see related information
Date Initiated by Firm November 06, 2013
Date Posted December 24, 2013
Recall Status1 Terminated 3 on March 23, 2017
Recall Number Z-0569-2014
Recall Event ID 66713
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 NY 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.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 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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