Abbott Molecular, Inc. recall records

20 reported ongoing

24 records in this archive. Latest source date Apr 28, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Alinity m System, Part No. 08N53-002

There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, ...

Official source for Alinity m System, Part No. 08N53-002

Reasons in these listed records

  • There is a potential for abnormal (non-sigmoidal) amplification curves.
  • There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
  • There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
  • There is an issue with the installation of updated camera firmware on the system.

These examples come from this result page and are not a ranking of every recall reason.

Checking Abbott Molecular, Inc.

Is there a recall on abbott molecular, inc. right now?

This archive contains 24 records, including 20 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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