FDADecember 6, 2022device
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
What to do
FDA enforcement status: Ongoing
Brands named
future diagnostics solutions b vfuturefuture diagnostics
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAdirectCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-22026-04-30
- FDABioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.2026-04-22
- FDABW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic Tip Steerable, Product Number 6DYNTP001;2026-04-10
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