Recall Z-1398-2015 ยท CEM Electrode, Ion Specific, Potassium
Siemens Healthcare Diagnostics, Inc.
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
| Date | Apr 7, 2015 (initiated Feb 24, 2015) |
| Status | Terminated |
| 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. |
| 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 | 5981 |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970330 | DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE Dade Intl., Inc., Apr 14, 1997 |