FDA-Device2023-02-01Class II
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Future Diagnostics Solutions B.V.
Hazard
Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
Sold states
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
Affected count
342 kits
Manufactured in
Nieuweweg 279, N/A, Wijchen, N/A, Netherlands
Products
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1016-2023Don't want to check this manually?
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