Z-2079-2014Class II

RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests)...

Name: Z-2079-2014 RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests)...
Creator: Siemens Healthcare Diagnostics Inc
Published: 2014-05-23
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-05-23 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics Inc began a recall of RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement... on 2014-05-23. FDA classified it as Class II and gives the reason as "RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-)". 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-2079-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-23
Posted: 2014-07-18
Terminated: 2015-06-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part Number: 10491447 RAPIDPoint 500 Measurement Cartridge Lactate (100 Tests) Part Number:10844813
Product code: KHP Acid, Lactic, Enzymatic Method
Reason for recall: RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-)
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on May 27, 2014 both in the United States and elsewhere for communication with affected customers. This notice informs customers of the issue with the RAPIDPoint 500 Measurement cartridges. Questions contact: Siemens Customer Care Center or your local Siemens technical support representative at 877-229-3711. What steps can be taken to mitigate the issue: " Install a new RAPIDPoint 500 Measurement Cartridge. or " Install a 405 Measurement Cartridge - The RAPIDPoint 405 cartridge is available in four sizes: Since the Lactate parameter is not available on the RAPIDPoint 405 cartridge, however, you will need to arrange to get your lactate results from other instruments in your central laboratory. or " Use an alternative system to obtain your electrolyte values.
Quantity in commerce: 20,507 cartridges
Distribution: Nationwide Foreign: U.A.E. Albania Austria Australia Bosnia Herzeg. Belgium Bulgaria Bahrain Brazil Canada Switzerland P.R. China Colombia Czech Republic Germany Denmark Algeria Estonia Egypt Spain Finland France United Kingdom Georgia Greece Hong Kong Croatia Hungary Indonesia Ireland Israel India Italy Japan Republic Korea Kuwait Lithuania Luxembourg Latvia Malaysia Mexico Netherlands Norway New Zealand Peru Poland Portugal Qatar Romania Serbia Russian Fed. Saudi Arabia Sweden Singapore Slovenia Turkey Taiwan
Product codes and lots: Serial Numbers: 2334500011 through 2412705915

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2079-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2079-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-18

Product code KHP

K113216Class IRapidpoint 500 Blood Gas AnalyerSiemens Healthcare Diagnostics / cleared 2012-05-03

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)