Future Diagnostics Solutions B.V. recall records

1 reported ongoing

1 records in this archive. Latest source date Dec 6, 2022.

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

Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.

Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.

Class IIReported ongoing

Distribution: Worldwide distribution. US states of AZ, CA, CO, LA, OH, PA, and TX; Austria, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Spain, Sweden, and United Kingdom

Official source for Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. ...

Reasons in these listed records

  • Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.

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

Checking Future Diagnostics Solutions B.V.

Is there a recall on future diagnostics solutions b.v. 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.

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.

Keep checking