Reported Feb 1, 2023 · Ongoing
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Future Diagnostics Solutions B.V.
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: Future Diagnostics Solutions B.V. · Nieuweweg 279 · Wijchen, N/A · N/A
Is this the product you have?
- Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
- Lot codes and dates
- Catalog Number4K-IPT-00
- UDI-DI08719326045214-230915
- Lot NumbersM78559 M78560 M78636
- Amount recalled
- 342 kits
Where it was sold
Why it was recalled
Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Future Diagnostics Solutions B.V. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.