Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Summary
The FDA issued a Class II for Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay ki by Future Diagnostics Solutions B.V.. Reason: Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits..
Details
Source
Device Recall
External ID
Z-1016-2023
Action Date
2023-02-01
Status
Ongoing
Category
device
Product Description
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Lot/Code Info: Catalog Number: 4K-IPT-00 UDI-DI: 08719326045214-230915 Lot Numbers: M78559 M78560 M78636
Quantity Affected: 342 kits
Reason for Recall
Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay 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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-06
Company
Wijchen, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Future Diagnostics Solutions B.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Future Diagnostics Solutions B.V. have FDA actions?
This is the only FDA action we have on record for Future Diagnostics Solutions B.V. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1016-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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