Z-0102-2014Class II

Siemens RAPIDPoint 400 system blood gas analyzer

Name: Z-0102-2014 Siemens RAPIDPoint 400 system blood gas analyzer
Creator: Siemens Healthcare Diagnostics Inc
Published: 2012-09-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-09-17 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics Inc began a recall of Siemens RAPIDPoint 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases... on 2012-09-17. FDA classified it as Class II and gives the reason as "RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0102-2014
Classification: Class II
Status: Terminated
Initiated: 2012-09-17
Posted: 2013-10-29
Terminated: 2015-04-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens RAPIDPoint 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: Siemens Healthcare sent an Urgent Field Safety Notification letter dated September 2013 via Federal Express, to affected Siemens domestic customers. Effected Siemens customers outside the US was provided a copy of the Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each countries local regulations and procedures. Previously Siemens Healthcare had issued a Customer Notification on August 23, 2012. The letter identified the affected product, issue, information to mitigate the issue and actions to be taken. The firm will issue an upgrades software to users. For questions contact your local Customer Care Center - Technical Support Representative at 1-877-229-3711.
Quantity in commerce: 828 units
Distribution: Worldwide Distribution - USA Nationwide and in the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Brazil, Brunei, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Fren.Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Mayotte, Netherlands, New Caledonia, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, U.A.E., United Kingdom, Vatikancity, Venezuela, Vietnam,
Product codes and lots: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0102-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0102-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-29
Z-0103-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-29
Z-0104-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-29
Z-0105-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-29
Z-0106-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-29
Z-0107-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-29
Z-0108-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-29

Product code CHL

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)