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U.S. Department of Health and Human Services

Class 3 Device Recall N Latex IgM

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  Class 3 Device Recall N Latex IgM see related information
Date Initiated by Firm January 15, 2015
Date Posted March 17, 2015
Recall Status1 Terminated 3 on August 17, 2016
Recall Number Z-1289-2015
Recall Event ID 70385
510(K)Number K032014  
Product Classification Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
Product N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec Systems. The determination of IgM aids in the evaluation of the patient's immune system.

Code Information Catalog # OQAC11, lots 44018, 44019 and 44042, expiration 4/3/2015
Recalling Firm/
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact Customer Support
Manufacturer Reason
for Recall
Complaints have been confirmed on failed proficiency testing due to serum samples recovering too low when using some N Latex IgM reagent kit lots 44018, 44019 and 44042.
FDA Determined
Cause 2
Nonconforming Material/Component
Action The firm, Siemens, sent an "Urgent Medical Device Recall" letter dated January 2015 to its customers on January 13, 2015. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Discontinue use of the affected lots and discard any remaining material; Identify if IgM quotient was overestimated due to falsely low IgM results with serum sample; Reconsider patient diagnosis taking other patient data into consideration.; When other patient data does not support the result for an intrathecal IgM synthesis or inflammation, re-measurement of samples may be considered using and alternative lot. In addition, Siemens requested customers to review this letter with their Medical Director; to complete and return the attached Effectiveness Check/Product Replacement form via fax to Customer Care Center at (312) 275-7795; 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 800-441-9250 or email: aydee.I.crawford@siemens.com or your local Siemens technical support representative.
Quantity in Commerce 26
Distribution Worldwide Distribution: US distribution in states of: UT , CO, CA , FL , NY , OH , NC and country of : Canada.
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 = CFN and Original Applicant = DADE BEHRING, INC.