Z-2816-2015Class II

Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813

Name: Z-2816-2015 Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813
Creator: Siemens Healthcare Diagnostics Inc
Published: 2015-08-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-08-24 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics Inc began a recall of Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: The RAPIDPoint 500 system is designed for professional... on 2015-08-24. FDA classified it as Class II and gives the reason as "RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results". 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-2816-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-24
Posted: 2015-09-24
Terminated: 2016-05-23
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCHb, FMetHb, FHHb, nBili
Product code: KHP Acid, Lactic, Enzymatic Method
Reason for recall: RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Siemens Healthcare sent an Urgent Field Safety Notice letter dated August 2015 to all affected customers. The notice identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Field Correction Effectiveness Check Form attached. For questions contact your Siemens Customer Care Center or ther local Siemens technical support representative.
Quantity in commerce: 49 cartridges
Distribution: Worldwide Distribution - US Nationwide and the countries of Canada, Albania, Austria, Australia, Bosnia Herzeg., Bangladesh, Belgium, Brazil, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Denmark, Estonia, Spain, Finland, France, Great Britain, Georgia, Greece, Croatia, Hungary, Ireland, India, Italy, Lithuania, Luxembourg, Latvia, Macedonia, Malaysia, Netherlands, Norway, New Zealand, Poland, Portugal, Paraguay, Romania, Sweden, Singapore, Slovenia, Slovakia, Turkey, Taiwan, South Africa, Unit.Arab Emirates
Product codes and lots: Serial Numbers: 2517102517 through 2519000012. Cartridges within this serial number range that have a green dot on the box and/or the cartridge are not affected

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2816-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2813-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-23
Z-2814-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-23
Z-2815-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-23
Z-2816-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-23

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