Agency classClass IIOur severity:High FDA (Devices)·Z-0862-2021·Announced 2021-01-20

Siemens Atellica IM 1300 Analyzer Software Recall for Discrepant Results

Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers with software version 1.23.2 or lower because the software may report discrepant patient results.

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 involves a risk of harm (discrepant patient results) where specific injuries or illnesses have not yet been reported in the source text.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 1,095 units of the Atellica IM 1300 Analyzer. The recall involves units equipped with software version 1.23.2 (SMN 11469032) or lower. The Atellica IM 1300 is an in vitro diagnostic device intended for the qualitative and quantitative analysis of various body fluids using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology.

The recall was initiated because multiple issues in the affected software versions may lead to the reporting of discrepant patient results. The FDA has classified this as a Class II recall. The affected units were distributed worldwide, including in the United States and numerous international locations.

Healthcare facilities and users of the Atellica IM 1300 Analyzer should contact Siemens Healthcare Diagnostics for instructions on how to address the software issues and ensure accurate patient results.

The recalled product

Product: Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and…
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostic
Hazard: software-defect
inaccurate-results
Affected units: 1,095

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)

Software (SW) versions V1.23.2 (SMN 11469032) or lower

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.

See all 3 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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