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U.S. Department of Health and Human Services

Class 2 Device Recall Future Diagnostics STATIntraOperativeIntactPTH (STATIOIPTH) Immunoassay kit

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 Class 2 Device Recall Future Diagnostics STATIntraOperativeIntactPTH (STATIOIPTH) Immunoassay kitsee related information
Date Initiated by FirmDecember 06, 2022
Date PostedJanuary 25, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1016-2023
Recall Event ID 91344
510(K)NumberK000471 
Product Classification Radioimmunoassay, parathyroid hormone - Product Code CEW
ProductFuture Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Code Information Catalog Number: 4K-IPT-00 UDI-DI: 08719326045214-230915 Lot Numbers: M78559 M78560 M78636
Recalling Firm/
Manufacturer		 Future Diagnostics Solutions B.V.
Nieuweweg 279
Wijchen Netherlands
Manufacturer Reason
for Recall		Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 12/06/2022, the firm send a Recall Notice via email to customer informing them that The PTH kit 4K-IPT-00 with lot numbers: M78559, M78560 and M78636 can occasionally give a high duplicate %CV outside the recommended maximum of 15%CV. As a result of the failure in the duplicate CV requires a repeat run it may cause a delay in the patient result turnaround time or in system calibration depending on what samples are run and can lead to a wrong sample result. Actions to be taken by customers: -Immediately identify and quarantine the affected lot numbers. -Further instructions will be provided by the Future Diagnostics. For questions, send an email to fieldsafety@future-diagnostics.nl.
Quantity in Commerce342 kits
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CEW
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