Z-1398-2015Class II

QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry...

Name: Z-1398-2015 QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-02-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-02-24 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module. Intended Use of... on 2015-02-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1398-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-24
Posted: 2015-04-07
Terminated: 2017-02-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: CEM Electrode, Ion Specific, Potassium
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Catalog Number S640, Siemens Material Number (SMN) 10444872, Lot Number 4MD707

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1398-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1398-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-07

Product code CEM

K970330Class IIDade Indirect Imt System with Tco2 ElectrodeDade Intl., Inc. / cleared 1997-04-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)