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 Solution IM1600 Analyzer Recalled by Siemens Healthcare Diagnostics, Inc. Due to Insufficient sample may not be detected when using...

Date: May 7, 2020
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 Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026

Quantity: 1329

Why Was This Recalled?

Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 analyzers.

Where Was This Sold?

This product was distributed to 1 state: DC

Affected (1 state)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