Z-2912-2016Class III

Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161

Name: Z-2912-2016 Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161
Creator: Siemens Healthcare Diagnostics Inc
Published: 2016-09-02
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-09-02 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics Inc began a recall of Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161 on 2016-09-02. FDA classified it as Class III and gives the reason as "Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2912-2016
Classification: Class III
Status: Terminated
Initiated: 2016-09-02
Posted: 2016-09-30
Terminated: 2017-08-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161
Product code: JFS Coulometric, Chloride
Reason for recall: Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge
Root cause tag: manufacturing process
FDA 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 in commerce: 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
Product codes and lots: Serial Numbers:2610900214 through 2621001325 Expiry Dates: Sept 13, 2016 through Dec. 6, 2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2912-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2912-2016	Class III	Terminated	Voluntary: Firm initiated	2016-10-12	2016-09-30
Z-2913-2016	Class III	Terminated	Voluntary: Firm initiated	2016-10-12	2016-09-30

Product code JFS

K002738Class IIBayer Rapidpoint 400 SystemBayer Corp. / cleared 2000-12-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)