Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Reported: February 1, 2023 Initiated: December 6, 2022 #Z-1016-2023
Product Description
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Reason for Recall
Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
Details
- Recalling Firm
- Future Diagnostics Solutions B.V.
- Units Affected
- 342 kits
- Distribution
- 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
- Location
- Wijchen, N/A
Frequently Asked Questions
What product was recalled? ▼
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.. Recalled by Future Diagnostics Solutions B.V.. Units affected: 342 kits.
Why was this product recalled? ▼
Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 1, 2023. Severity: Moderate. Recall number: Z-1016-2023.
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