CLASS II Device recall · Reported 6 Feb 2019 · FDA Enforcement Report

Atellica IM 1600 Analyzer: In vitro diagnostic testing recalled

Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens, distributed nationwide in the US. The recall was initiated on 26 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware in V 1.14.2 and lower.

Quantity recalled264

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0781-2019
FDA event ID: 81380
Recalling firm: Siemens Healthcare Diagnostics, Tarrytown, NY
Classification: Class II
Status: Terminated
Recall initiated: 26 Sep 2018
FDA classified: 29 Jan 2019
Reported: 6 Feb 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

26 Sep 2018	Recall initiated by company
29 Jan 2019	Classified by FDA	+125 days
6 Feb 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH 930 Analyzer; Atellica¿ Sample Handler Prime

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Siemens Material Number (SMN) :11066000

Where it was distributed

Worldwide distributions - US Nationwide and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. China, Poland, Portugal, Republic Korea, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, U.A.E., United Kingdom, Vietnam.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Software in V 1.14.2 and lower.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 81380

This product is part of a recall event; the main page for the event is Atellica CH 930 Analyzer recalled by Siemens Healthcare Diagnostics.

Reported	Class	Recall	Company	Reason	Where
6 Feb 2019	CLASS II	Atellica CH 930 Analyzer recalled by Siemens Healthcare Diagnostics	Siemens Healthcare Diagnostics	Device Malfunction	Nationwide
6 Feb 2019	CLASS II	Atellica IM 1300 Analyzer recalled by Siemens Healthcare Diagnostics	Siemens Healthcare Diagnostics	Device Malfunction	Nationwide
6 Feb 2019	CLASS II	Atellica Sample Handler Prime recalled by Siemens Healthcare Diagnostics	Siemens Healthcare Diagnostics	Device Malfunction	Nationwide

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