PlainRecalls
FDA Devices Moderate Class II Terminated

RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part Number: 10491447 RAPIDPoint 500 Measurement Cartridge Lactate (100 Tests) Part Number:10844813

Reported: July 30, 2014 Initiated: May 23, 2014 #Z-2079-2014

Product Description

RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part Number: 10491447 RAPIDPoint 500 Measurement Cartridge Lactate (100 Tests) Part Number:10844813

Reason for Recall

RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-)

Details

Units Affected
20,507 cartridges
Distribution
Nationwide Foreign: U.A.E. Albania Austria Australia Bosnia Herzeg. Belgium Bulgaria Bahrain Brazil Canada Switzerland P.R. China Colombia Czech Republic Germany Denmark Algeria Estonia Egypt Spain Finland France United Kingdom Georgia Greece Hong Kong Croatia Hungary Indonesia Ireland Israel India Italy Japan Republic Korea Kuwait Lithuania Luxembourg Latvia Malaysia Mexico Netherlands Norway New Zealand Peru Poland Portugal Qatar Romania Serbia Russian Fed. Saudi Arabia Sweden Singapore Slovenia Turkey Taiwan
Location
Norwood, MA

Frequently Asked Questions

What product was recalled?
RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part Number: 10491447 RAPIDPoint 500 Measurement Cartridge Lactate (100 Tests) Part Number:10844813. Recalled by Siemens Healthcare Diagnostics Inc. Units affected: 20,507 cartridges.
Why was this product recalled?
RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-)
Which agency issued this recall?
This recall was issued by the FDA Devices on July 30, 2014. Severity: Moderate. Recall number: Z-2079-2014.