CLASS II Device recall · Reported 8 Jul 2015 · FDA Enforcement Report

The Rapidlab 1265 system is a blood gas analyzer used recalled

Siemens Healthcare Diagnostics is recalling The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood, distributed nationwide in the US. The recall was initiated on 6 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSiemens Material Number (SMN): 10321852, 10470366, 10491395, 10335524

Quantity recalled2713 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1962-2015
FDA event ID: 71073
Recalling firm: Siemens Healthcare Diagnostics, East Walpole, MA
Classification: Class II
Status: Terminated
Recall initiated: 6 May 2015
FDA classified: 2 Jul 2015
Reported: 8 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

6 May 2015	Recall initiated by company
2 Jul 2015	Classified by FDA	+57 days
8 Jul 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

D50 and D51 diagnostic error codes are not functional.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Georgia Puerto Rico

Questions about this recall

Is The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood recalled?

Yes. Siemens Healthcare Diagnostics recalled The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood on 6 May 2015. The recall is Class II and its status is Terminated. Recall number Z-1962-2015.

Why was it recalled?

D50 and D51 diagnostic error codes are not functional.

Which lots are affected?

Siemens Material Number (SMN): 10321852, 10470366, 10491395, 10335524

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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