Recalls / —
—#149372
Product
Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469
- FDA product code
- JFS — Coulometric, Chloride
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K110277
- Affected lot / code info
- Serial Numbers:2610900214 through 2621001325. Expiry Dates: Sept 13, 2016 through Dec. 6, 2016
Why it was recalled
Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics Inc
- Address
- 2 Edgewater Dr, Norwood, Massachusetts 02062-4637
Distribution
- 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
Timeline
- Recall initiated
- 2016-09-02
- Posted by FDA
- 2016-09-30
- Terminated
- 2017-08-07
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #149372. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.