Ortho-Clinical Diagnostics, Inc.: VITROS XT7600 Integrated System

Hazard

Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

Details from the source

Reason for recall: Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom. Quantity: 1,720 units (834 US, 886 OUS) Lot/code info: Code Information: UDI/DI: 10758750031610; Serial Numbers: J76000109 through J76001913 (inclusive).

UPC codes

10758750031610

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.