Atellica IM 1300 Analyzer Valves Recalled Due to Manufacturing Defect
Siemens is recalling Atellica IM 1300 diagnostic analyzer valves due to a manufacturing defect that may cause leaking and affect 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: This FDA Class II recall involves a manufacturing defect in a medical device that can impact diagnostic accuracy. Although no illnesses or injuries have been reported, the potential for inaccurate test results—which could affect patient care—represents a risk-of-harm scenario.
Plain-English summary
The Atellica IM 1300 Analyzer is a multi-component in vitro diagnostic system used in clinical laboratories to analyze patient specimens. Siemens Healthcare Diagnostics, Inc. is recalling affected units due to a manufacturing defect affecting internal valves.
The defective valves may malfunction and develop leaks over time. The leaking risk is elevated in valves subject to high pressure or high wear conditions. A leaking valve can impact the accuracy of test results produced by the analyzer.
Approximately 233 units are affected in the United States, with 233 additional units distributed internationally across more than 40 countries. Affected serial numbers range from IM00873 to IM01452, and from IRM00256xxxx to IRM01169xxxx (where xxxx represents any number).
Laboratories using affected equipment should contact Siemens Healthcare Diagnostics, Inc. for service guidance or device replacement options. Healthcare providers should verify their equipment serial numbers against the affected serial number ranges provided in this recall notice.
The recalled product
- Product
- Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
- 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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