Reported May 9, 2018 · Terminated

Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.

Siemens Healthcare Diagnostics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005

Is this the product you have?

  • Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
Lot codes and dates
  • UDI 00630414007960
Amount recalled
N/A

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 12, 2020 · Data as of Sep 19, 6:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.