Reported Aug 5, 2020 · Terminated

Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below

Abbott GmbH & Co. KG

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: Abbott Gmbh & Co. KG · Max-Planck-Ring 2 · Wiesbaden, N/A · N/A

Is this the product you have?

  • Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below
Lot codes and dates
  • All serial numbers of System Control Module
Amount recalled
3166

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Quality Control results were not properly evaluated for QC failures.

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 Apr 10, 2024 · 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.