FDAClass IIJuly 8, 2015

The Rapidlab 1260 system is a blood gas analyzer used recall

The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial…

Why was The Rapidlab 1260 system is a blood gas analyzer used recalled?

D50 and D51 Diagnostic error codes are not functional.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Siemens Material Number (SMN): 10321846, 10491394, 10339910

Product
The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial…
Recalling firm
Siemens Healthcare Diagnostics, Inc
Quantity
122 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.
Recall date
July 8, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls