FDA Enforcement 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

Recall: Z-2079-2014 · Reported July 30, 2014

Enforcement

Recall Number: Z-2079-2014
Event ID: 68437
Classification: Class II
Status: Terminated
Product Type: Devices
Firm: Siemens Healthcare Diagnostics Inc
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: July 30, 2014
Initiation Date: May 23, 2014
Classification Date: July 18, 2014
Termination Date: June 10, 2015
Address: 2 Edgewater Drive, Norwood, MA, 02062, United States

Description

Reason

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

Code Info

Serial Numbers: 2334500011 through 2412705915

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

Quantity

20,507 cartridges