Recall Z-1016-2023— Future Diagnostics Solutions B.V.

Name: FDA recall Z-1016-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-06

Class II · Ongoing

Class II FDA medical device recall by Future Diagnostics Solutions B.V., initiated 2022-12-06. It names one FDA 510(k) clearance: K000471. Product: Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.. Reason: Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits..

Recalling firm: Future Diagnostics Solutions B.V.
Classification: Class II
Status: Ongoing
Initiated: 2022-12-06
Firm location: Wijchen, N/A, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K000471 — FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KITFuture Diagnostics B.V.·cleared 2000-04-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.