Recall Z-2815-2015 ยท KHP Acid, Lactic, Enzymatic Method
Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are test
| Date | Sep 24, 2015 (initiated Aug 24, 2015) |
| Status | Terminated |
| Reason | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results |
| Root cause | Process control |
| Action | Siemens Healthcare sent an Urgent Field Safety Notice letter dated August 2015 to all affected customers. The notice identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Field Correction Effectiveness Check Form attached. For questions contact your Siemens Customer Care Center or ther local Siemens technical support representative. |
| Quantity | 982 cartridges |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Canada, Albania, Austria, Australia, Bosnia Herzeg., Bangladesh, Belgium, Brazil, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Denmark, Estonia, Spain, Finland, France, Great Britain, Georgia, Greece, Croatia, Hun |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113216 | RAPIDPOINT 500 BLOOD GAS ANALYER Siemens Healthcare Diagnostics, May 3, 2012 |