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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension QuikLYTE Dilution Check

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  Class 2 Device Recall Dimension QuikLYTE Dilution Check see related information
Date Initiated by Firm February 24, 2015
Date Posted April 07, 2015
Recall Status1 Terminated 3 on February 01, 2017
Recall Number Z-1398-2015
Recall Event ID 70627
510(K)Number K970330  
Product Classification Electrode, ion specific, potassium - Product Code CEM
Product QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module.
Intended Use of the QuikLYTE module : The Na+, K+, Cl and TCO2 methods on the Dimension clinical chemistry system with the QuikLYTE module are in vitro diagnostic tests intended for the quantitative measurement of sodium, potassium, chloride and total carbon dioxide in human serum and heparinized plasma. They are also intended for the quantitative measurement of Na+, K+ and Cl- in urine.
Code Information Catalog Number S640, Siemens Material Number (SMN) 10444872, Lot Number 4MD707 
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
A positive bias beyond 5% resulting in a dilution check failure or an unnecessary dilution check correction if the positive bias is greater than 1% and less than 5%. The dilution check correction would be detected by QC; however, if not detected by QC, the calibration curve would be decreased and cause elevated sodium, potassium and chloride patient results.
FDA Determined
Cause 2
Under Investigation by firm
Action An Urgent Medical Device Recall letter, dated February 2015, was provided to all Dimension¿ system customers who received the affected lot to notify them that Siemens confirmed customer complaints of failing dilution checks when using QuikLYTE Dilution Check lot 4MD707. The letter also instructed them to immediately discontinue use and discard all inventory of Dimension QuikLYTE¿ Dilution Check lot 4MD707. Siemens offered a no charge replacement with a non-impacted lot.
Quantity in Commerce 5981
Distribution Worldwide Distribution.
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 = CEM and Original Applicant = DADE INTL., INC.