Beckman Coulter Biomedical Division recall records

1 reported ongoing

1 records in this archive. Latest source date Sep 6, 2023.

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

AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the re...

The firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU) reagent on-board stability claims, which may cause control failures and/or erroneous patient samples results. The Complaint handling unit has received a total ...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of NY, CA, MS, GA, PA, SC, WA, TN, AL, AK, OR, MO, KS, FL, LA, OH, TX, NJ, MI, WV, MD, IL, RI, VA, NC, IN, OK, NV,...

Official source for AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in...

Reasons in these listed records

  • The firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU) reagent on-board stability claims, which may cause control failures and/or erroneous patient samples results. The Complaint handling unit has received a total of 2 safety cases (C...

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

Checking Beckman Coulter Biomedical Division

Is there a recall on beckman coulter biomedical division right now?

This archive contains 1 records, including 1 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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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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