Siemens Healthcare Diagnostics Inc recalls Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469

Recall date

September 2, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2913-2016

FDA classification

Class III

Brand / firm

Siemens Healthcare Diagnostics Inc

Sold / distributed

Nationwide: Foreign: Canada, Bahamas,Germany, Japan, Mexico.Belgium, Italy,Spain, Korea, France, Austria, Korea, France, Poland, Australia, china, AE, Bangladesh, Columbia, Czechkoslovakia, Bosnia

Why it was recalled

Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469