CLASS II ONGOING Device recall · Reported 1 Feb 2023 · FDA Enforcement Report
Future Diagnostics Stat-IntraOperative-Intact-Pth recalled
Future Diagnostics Solutions B.V is recalling Future Diagnostics Stat-IntraOperative-Intact-Pth (Stat-io-i-pth) Immunoassay kit, distributed in 7 states. The recall was initiated on 6 Dec 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1016-2023
- FDA event ID
- 91344
- Recalling firm
- Future Diagnostics Solutions B.V, Wijchen, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Dec 2022
- FDA classified
- 25 Jan 2023
- Reported
- 1 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 6 Dec 2022 | Recall initiated by company | |
| 25 Jan 2023 | Classified by FDA | +50 days |
| 1 Feb 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Where it was distributed
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
Questions about this recall
Is Future Diagnostics Stat-IntraOperative-Intact-Pth (Stat-io-i-pth) Immunoassay kit recalled?
Yes. Future Diagnostics Solutions B.V recalled Future Diagnostics Stat-IntraOperative-Intact-Pth (Stat-io-i-pth) Immunoassay kit on 6 Dec 2022. The recall is Class II and its status is Ongoing. Recall number Z-1016-2023.
Why was it recalled?
Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
Which lots are affected?
Catalog Number: 4K-IPT-00 UDI-DI: 08719326045214-230915 Lot Numbers: M78559 M78560 M78636
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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