Reported Jun 24, 2020 · Terminated

Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.

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

Is this the product you have?

  • Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
Lot codes and dates
  • List Number03R67-01: All serial numbers
Amount recalled
421 serial numbers

Where it was sold

Why it was recalled

There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.

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 Jan 31, 2023 · 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.