Siemens Rapidlab 1260 Blood Gas Analyzer Recalled for Diagnostic Error Codes
Siemens Healthcare Diagnostics is recalling 122 Rapidlab 1260 blood gas analyzers because specific diagnostic error codes are not functional.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves non-functional diagnostic error codes on a medical device used for critical blood testing, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 122 units of the Rapidlab 1260 blood gas analyzer system. The recall is due to a defect where D50 and D51 diagnostic error codes are not functional. The Rapidlab 1260 is used for laboratory testing of blood gases, electrolytes, metabolites, and CO-oximetry in arterial, venous, and capillary whole blood samples.
The affected devices are identified by Siemens Material Numbers (SMN) 10321846, 10491394, and 10339910. These devices were distributed worldwide, including in the United States (nationwide including Puerto Rico) and numerous international locations such as Argentina, Australia, Brazil, Canada, China, Germany, India, Japan, and the United Kingdom.
This is an FDA Class II recall. Users of the affected devices should contact Siemens Healthcare Diagnostics for further instructions on how to address the non-functional diagnostic error codes.
The recalled product
- Product
- The Rapidlab 1260 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.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 122
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Siemens Material Number (SMN): 10321846
- 10491394
- 10339910
Distribution
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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