Siemens Atellica IM 1600 Analyzer Recalled for Reporting Factor Errors
Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzer systems because reporting and conversion factors may not apply to all connected analyzers.
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, which typically involves a situation where use of the product may cause temporary or medically reversible health consequences. The hazard involves potential diagnostic errors (incorrect reporting factors) which is a risk-of-harm scenario where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica IM 1600 Analyzer system, which is used for in vitro diagnostic testing of clinical specimens. The recall is due to a software issue where reporting and conversion factors may not be applied to all analyzers when more than one immunoassay analyzer is connected to a single solution system.
The affected products were distributed in Florida, France, Spain, Sweden, the United Kingdom, and Germany. The specific UDI for the recalled units is 00630414002026.
Healthcare facilities using these systems should contact Siemens Healthcare Diagnostics for instructions on how to resolve the issue. No specific instructions for individual consumers are provided in the source text, as this is a professional medical device.
The recalled product
- Product
- Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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 (1)
- UDI 00630414002026
Distribution
Distribution scope not specified by the agency.
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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