Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Atellica IM 1600 Analyzer - automated Recalled by Siemens Healthcare Diagnostics, Inc. Due to Lots incompatible with Test Definition (TDef) Version 1.4,...

Date: April 13, 2022
Company: Siemens Healthcare Diagnostics, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc. directly.

Affected Products

Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000

Quantity: 2,321

Why Was This Recalled?

Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report