FDA Recall Terminated

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.

Recall: Z-1398-2015 · Initiated February 24, 2015

Recall

Recall Number: Z-1398-2015
Event Number: 70627
Firm: Siemens Healthcare Diagnostics, Inc.
FEI Number: 2517506
Product Code: CEM
Status: Terminated
Root Cause: Under Investigation by firm
Initiated: February 24, 2015
Posted: April 7, 2015
Terminated: February 1, 2017
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

Description

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.

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.

Distribution

Worldwide Distribution.

Quantity

5981