Siemens Rapidlab 1265 Blood Gas Analyzer Recalled for Diagnostic Error Code Failure
Siemens Healthcare Diagnostics is recalling 2,713 Rapidlab 1265 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 involves a medical device with a functional defect that could impact diagnostic accuracy, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 2,713 units of the Rapidlab 1265 blood gas analyzer system. The device is used for laboratory testing of blood gases, electrolytes, metabolites, and CO-oximetry in arterial, venous, and capillary whole blood samples.
The recall is due to a defect where D50 and D51 diagnostic error codes are not functional. This issue affects the device's ability to properly report specific diagnostic errors.
The affected devices were distributed worldwide, including in the United States (nationwide including Puerto Rico) and numerous international countries. Siemens Material Numbers (SMN) for the affected units are 10321852, 10470366, 10491395, and 10335524. Users should contact Siemens Healthcare Diagnostics for further instructions on how to address this defect.
The recalled product
- 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.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 2,713
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 (4)
- Siemens Material Number (SMN): 10321852
- 10470366
- 10491395
- 10335524
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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