Reported Jul 30, 2014 · Terminated
RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part…
Siemens Healthcare Diagnostics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics Inc · 2 Edgewater Drive · Norwood, MA · 02062
Is this the product you have?
- RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge
- Lactate (750 Tests) Part number
10491449RAPIDPoint 500 Measurement Cartridge
- Lactate (400 Tests) Part Number10491448 RAPIDPoint 500 Measurement Cartridge
- Lactate (250 Tests) Part Number10491447 RAPIDPoint 500 Measurement Cartridge
- Lactate (100 Tests) Part Number10844813
- Lot codes and dates
- Serial Numbers2334500011 through 2412705915
- Amount recalled
- 20,507 cartridges
Where it was sold
- Nationwide
- GA
Why it was recalled
RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-)
This product could cause temporary or reversible health problems — stop using it.
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