Recalls / —
—#139658
Product
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number: 10491448 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 product code
- KHP — Acid, Lactic, Enzymatic Method
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K113216
- Affected lot / code info
- Serial Numbers: 2517102517 through 2519000012. Cartridges within this serial number range that have a green dot on the box and/or the cartridge are not affected
Why it was recalled
RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics Inc
- Address
- 2 Edgewater Dr, Norwood, Massachusetts 02062-4637
Distribution
- 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
Timeline
- Recall initiated
- 2015-08-24
- Posted by FDA
- 2015-09-24
- Terminated
- 2016-05-23
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #139658. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.