Z-1962-2015Class II

The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes...

Name: Z-1962-2015 The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2015-05-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-05-06 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and... on 2015-05-06. FDA classified it as Class II and gives the reason as "D50 and D51 diagnostic error codes are not functional". 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-1962-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-06
Posted: 2015-07-02
Terminated: 2017-08-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples.
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: D50 and D51 diagnostic error codes are not functional.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent an Urgent Field Safety Notice April 2015, to all affected customers. Customers were notified of the recall beginning on May 6, 2015 via Federal Express. Foreign customers were notified starting on May 5, 2015 via method determined by each countries local regulations and procedures. The notification informs customers of the issue and asks customers to do the following: Ensure that the Glucose and Lactate sensor contacts are aligned and completely seated with the contacts on the analyzer, Analyze a minimum of 2 levels of quality control material after installing the sensors, as indicated in the RAPIDLab 1200 Operator's Guide, Review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 7 days. Retain this letter with your laboratory records, and forward this letter to those who may have received this product. For further questions please call (800) 242-3233.
Quantity in commerce: 2713 devices
Distribution: Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Argentina, Australia, Austria, Belgium, Bosnia, Herzog,Brazil, Brunei, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany,Georgia, Greece, Hong Kong, Iceland, India, Indonesia, Ireland, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, P.R. China, Peru, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, Venezuela and Vietnam.
Product codes and lots: Siemens Material Number (SMN): 10321852, 10470366, 10491395, 10335524

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1962-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1961-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1962-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02

Product code CGA

K073537Class INeonatal Bilirubin on Rapidlab Models 1245 and 1265Siemens Medical Solutions Diagnostics / cleared 2008-06-27

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)