Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2913-2016

September 02, 2016

Class III

Product summary

Firm
Siemens Healthcare Diagnostics Inc
Event
Event 75108
Status
Terminated
Classification
Class III
Quantity
6638 cartridges
Official record key
device-enforcement:Z-2913-2016

Official wording

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

Code information: Serial Numbers:2610900214 through 2621001325. Expiry Dates: Sept 13, 2016 through Dec. 6, 2016

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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