Terminated

Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 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 tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCHb, FMetHb, FHHb, nBili

FDA Recall Z-2813-2015 · Posted 2015-09-24

Recalling FirmSiemens Healthcare Diagnostics Inc

Recall StatusTerminated

Product CodeKHP

Date Initiated2015-08-24

Date Terminated2016-05-23

Product Quantity2079 cartridges

Reason for Recall

RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results

Firm 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.

Root Cause

Process control

Distribution Pattern

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, Hungary, Ireland, India, Italy, Lithuania, Luxembourg, Latvia, Macedonia, Malaysia, Netherlands, Norway, New Zealand, Poland, Portugal, Paraguay, Romania, Sweden, Singapore, Slovenia, Slovakia, Turkey, Taiwan, South Africa, Unit.Arab Emirates

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113216RAPIDPOINT 500 BLOOD GAS ANALYERSiemens Healthcare Diagnostics · 2012-05-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.