Ortho-Clinical Diagnostics, Inc.: VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, usi

Hazard

MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable

Details from the source

Reason for recall: MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable Distribution: Nationwide including Puerto Rico and Bermuda Foreign: Australia Belgium Brazil Canada Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Portugal Russia Singapore Spain Sweden The Netherlands United Kingdom Quantity: 4895 units Lot/code info: UDI: 10758750002740 Serial Number Range: J56000143- J56004477

UPC codes

10758750002740

Source

Official record: FDA (Device enforcement) ↗

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