Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF recall — FDA Z-1016-2023
Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
Overview of recall records associated with Future Diagnostics Solutions B.V., including dates, categories and classifications where available.
Classification mix: Class II: 1.
Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
This page summarizes recall records in which the official source identifies Future Diagnostics Solutions B.V. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.