Future Diagnostics STAT-IO-I-PTH Kit Recall: High Variability Risk

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Recalling firmFuture Diagnostics Solutions B.V.Nieuweweg 279, N/A · Wijchen, N/A N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Future Diagnostics is recalling STAT-IO-I-PTH Immuno: a test kit for PTH levels. The kits have high variability due to a problem with the accuspheres inside, which could lead to inaccurate test results.

Why it’s dangerous

The kits contain accuspheres that cause high coefficient of variability (CV). This means test results may be inconsistent, leading to inaccurate measurements of PTH levels. Inconsistent results could affect medical decisions.

Who’s affected

Users of the STAT-IO-I-PTH Immunoassay kit REF 4K-IPT-00 are affected. Healthcare professionals using these kits for PTH testing are most at risk of inaccurate results.

How to tell if you have this one

Check for the catalog number 4K-IPT-00 on the kit. Affected lots are M78559, M78560, and M78636. The kits were sold with UDI-DI: 08719326045214-230915.

Brand
Future Diagnostics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Look for catalog number 4K-IPT-00 and affected lot numbers M78559, M78560, or M78636.

✎ GovInfoNow

Questions people ask

What is the problem with these kits?

The kits have high coefficient of variability (CV) due to an issue with the accuspheres inside, which can cause inconsistent test results.

Which lots are affected?

Affected lots are M78559, M78560, and M78636.

What should I do if I have this kit?

The recall does not specify a remedy, so check with Future Diagnostics Solutions B.V. for guidance.

Take action

Contact Future Diagnostics

We’ve drafted a message you can send Future Diagnostics to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1016-2023 — Future Diagnostics Future Diagnostics

Hello,

I own a Future Diagnostics that is covered by recall Z-1016-2023 from Future Diagnostics.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1016-2023 (December 6, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1016-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

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

Lower-risk recall