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FDAFDA · Food and drugs·Recall number Z-2079-2014

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

Published July 30, 2014 · Recall initiated: May 23, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Siemens Healthcare Diagnostics Inc
Distributor
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
Lot
Serial Numbers: 2334500011 through 2412705915
Risk classification
Class II
Area (FDA)
device
Country
United States

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