Reported Apr 1, 2020 · Terminated

LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module…

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?

  • LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.
Lot codes and dates
    • LN 3R70-01
    • software version 2.6.2 and earlier
Amount recalled
2676 units

Where it was sold

Why it was recalled

Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.

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 Aug 8, 2023 · Data as of Sep 19, 5:31 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.