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U.S. Department of Health and Human Services

Class 2 Device Recall IMMULITE/ IMMULITE 1000 CMV IgM Assay

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  Class 2 Device Recall IMMULITE/ IMMULITE 1000 CMV IgM Assay see related information
Date Initiated by Firm August 30, 2016
Create Date October 27, 2016
Recall Status1 Terminated 3 on June 07, 2018
Recall Number Z-0319-2017
Recall Event ID 75090
510(K)Number K100433  
Product Classification Antibody igm,if, cytomegalovirus virus - Product Code LKQ
Product IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Identification Number (UDI) 00630414985718 (US); and REF/Catalog Number LKCM1 - 100 tests (OUS); SMN 10381296 (OUS), UDI 00630414963747 (OUS); IVD --- Made in UK Siemens Healthcare Diagnostics Products Ltd., Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL UK

For in vitro diagnostic use with the IMMULITE Systems Analyzers for the qualitative detection of IgM antibodies to Cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the determination of an acute CMV infection.
Code Information UDI 00630414985718/Catalog # LKCM1(D): Kit lot D0330;  UDI 00630414963747/Catalog # LKCM1: Kit lots 0330, 0331
Recalling Firm/
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
Manufacturer Reason
for Recall
Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and above.
FDA Determined
Cause 2
Under Investigation by firm
Action The firm, Siemens, issued an "Urgent Medical Device Recall" Letter (IMC16-22.A.US, dated 8/30/2016) in the US and an "Urgent Field Safety Notice" (IMC16-22.A.OUS, dated August 2016) Outside the US (OUS) starting on 8/30/2016 The notices instructed customers to discontinue use of and discard the affected kit lots listed in the customer notice; review your inventory of the products to determine your laboratory's replacement needs; review the UMDR and or the UFSN with their Medical Director, In the US, the method of distribution is FedEx and Outside the US the distribution is determined at the country level; complete and return the Field Correction Effectiveness Check Form via Fax to: Customer Care Center at (312) 275-7795 within 30 days, and retain this letter with your laboratory records, and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in Commerce US: 5 kits; Foreign: 372 kits
Distribution Worldwide distribution- US (Nationwide) and countries of: United Arab Emirates, Afghanistan, Angola, Argentina, Australia, Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Belarus, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Dominican Republic, Algeria, Ecuador, Egypt, Spain, France, Great Britain, Greece, Guatemala, Honduras, Hungary, India, Iraq, Italy, Jordan, Canary Islands, Kyrgyzstan, Rep. Korea (S), Kazakhstan, Lebanon, Lithuania, Luxembourg, Latvia, Macedonia, Mexico, Malaysia, Nicaragua, Netherlands, Norway, Nepal, Peru, Pakistan, Poland, Portugal, Paraguay, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, El Salvador, Syria, Turkmenistan, Tunisia, Turkey, Uruguay, Uzbekistan, Vietnam, Serbia,and South Africa.
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 = LKQ and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS