FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics Inc: Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161
- Recall number
- Z-2912-2016
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Product
- Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161
- Status
- Terminated
- Initiated
- 2016-09-02
- Posted
- 2016-09-30
- Terminated
- 2017-08-07
- Reason
- Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge
- Root cause
- Under Investigation by 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.
- Quantity
- 689 cartridges
- Distribution
- Nationwide: Foreign: Canada, Bahamas,Germany, Japan, Mexico.Belgium, Italy,Spain, Korea, France, Austria, Korea, France, Poland, Australia, china, AE, Bangladesh, Columbia, Czechkoslovakia, Bosnia
- Lot, serial or model codes
- Serial Numbers:2610900214 through 2621001325 Expiry Dates: Sept 13, 2016 through Dec. 6, 2016
- 510(k) numbers
- ["K002738"]
- PMA numbers
- not on file
- Product code
- JFS
- Firm FEI
- 3002637618
- Firm city
- Norwood
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28