Ortho-Clinical Diagnostics, Inc.: VITROS 3600 Immunodiagnostic System (New and Refurbished)

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: 489 units (46 US, 443 OUS) Lot/code info: Code Information: UDI/DI: (New) 10758750002979, (Refurbished) 10758750007103; Serial Numbers: J36001164 through J36001692 (inclusive).

UPC codes

10758750002979, 10758750007103

Source

Official record: FDA (Device enforcement) ↗

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