The Recall Desk
HighFDA (Devices)·Z-1253-2022·Announced 2022-06-15

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.

What this means for you

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.
Category
Medical Device — Immunoassay Analyzer
Hazard
  • erroneous-results
  • software-incompatibility

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.

Related recalls

Same category