Recall Z-1398-2015— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1398-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-24

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2015-02-24, terminated 2017-02-01. It names one FDA 510(k) clearance: K970330. 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.. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-02-24
Terminated: 2017-02-01
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K970330 — DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODEDade Intl., Inc.·cleared 1997-04-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.