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Terminated

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

FDA Recall Z-2913-2016 · Posted 2016-09-30

Recalling FirmSiemens Healthcare Diagnostics Inc
Recall StatusTerminated
Product CodeJFS
Date Initiated2016-09-02
Date Terminated2017-08-07
Product Quantity6638 cartridges

Reason for Recall

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

Firm Action

Siemens Healthcare issued An Urgent Field Safety Notice via e-mail to affected Siemens Healthcare Diagnostics Regional offices on September 2, 2016 both in the United States and outside of the United States, for communication with affected customers e: the bias of the chloride values. US accounts sent hard copy via Federal Express and requested to: Complete and return the Field Correction Effectiveness Check form attached to this letter within 7 days. Review this letter with your Medical Director. Questions:Contact your Siemens Customer Care Center or your local Siemens technical support representative.

Root Cause

Under Investigation by firm

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110277RAPIDPOINT 405 NEONATAL BILIRUBINSiemens Healthcare Diagnostics · 2011-08-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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