Siemens Atellica IM 1600 Analyzer Recalled for Potential Erroneous Test Results
Siemens recalled 2,321 Atellica IM 1600 Analyzers due to incompatibility with Test Definition Version 1.4, which may produce erroneous total T3 test results. Worldwide distribution affected.
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 medical device recall involves diagnostic equipment with potential to produce erroneous test results, creating risk of misdiagnosis and inappropriate medical treatment. No illnesses or injuries have been reported to date, limiting the score to a maximum of 3.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. has recalled the Atellica IM 1600 Analyzer, an automated immunoassay analyzer used in vitro diagnostic testing on clinical specimens. The recall affects 2,321 units distributed worldwide, including the United States.
The recall was initiated due to incompatibility between certain product lots and Test Definition (TDef) Version 1.4. This incompatibility may lead to the generation of erroneous total T3 (triiodothyronine) test results.
All lots with UDI 00630414002026 are affected by this recall.
The recalled product
- Product
- Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 2,321
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 All lots
Distribution
Distributed nationwide across the United States.
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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