Atellica analyzer valves recalled for manufacturing defect affecting diagnostic accuracy
Siemens recalls Atellica analyzers (CH 930, IM 1300, IM 1600) due to valve manufacturing defects that may cause leaking and affect clinical test result accuracy.
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: FDA Class II recall with potential for inaccurate clinical test results due to valve leakage in high-pressure applications. Classified as High under the rubric for risk-of-harm products where no injury has been reported.
Plain-English summary
Siemens Healthcare Diagnostics is recalling valves used in Atellica CH 930, Atellica IM 1300, and Atellica IM 1600 analyzers due to a manufacturing defect. The affected valves may wear and leak over time, particularly in high-pressure or high-wear applications. When valves leak, the system may produce inaccurate results for clinical tests.
For the Atellica IM 1600 specifically, the recall affects 123 units distributed nationwide in the United States and 751 units distributed internationally. Affected serial number ranges include IH00876 through IH01451 and IRH00258xxxx through IRH01169xxxx (where 'xxxx' represents any number).
Laboratory operators using the affected analyzers should contact Siemens Healthcare Diagnostics for guidance on valve inspection and replacement.
The recalled product
- Product
- Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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