—#134171

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.

FDA product code: CEM — Electrode, Ion Specific, Potassium
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K970330
Affected lot / code info: Catalog Number S640, Siemens Material Number (SMN) 10444872, Lot Number 4MD707

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Worldwide Distribution.

Timeline

Recall initiated: 2015-02-24
Posted by FDA: 2015-04-07
Terminated: 2017-02-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #134171. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.