Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. ...

FDA Recall #Z-1016-2023 — Class II — December 6, 2022

Recall #Z-1016-2023 Date: December 6, 2022 Classification: Class II Status: Ongoing

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.

Recalling Firm

Future Diagnostics Solutions B.V. — Wijchen, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

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

Code Information

Catalog Number: 4K-IPT-00 UDI-DI: 08719326045214-230915 Lot Numbers: M78559 M78560 M78636

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

Browse All Device Recalls Device Recall Stats Device Safety Home
Back to All Device Recalls