Product Wiki · Recalls · U.S. FDA — Device Enforcement

VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents — recall Z-1650-2013

U.S. FDA — Device Enforcement · United States · 2013-05-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1650-2013
Date of alert
2013-05-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ortho-Clinical Diagnostics
Product category
device
Product type
Devices
Reported risk: There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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