Clinical Diagnostic Systems

One device in the database

  • Model / Serial
    Lot 5470, expiry date: 24-May-2018 Lot 5430, expiry date: 01-Mar-2018 (not distributed in the US.) Lot 5178 was also affected by this issue, expired on 31-Mar-2017.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributors were notified via letter. Lot 5430 was not distributed in the US. Lot 5178 was also affected by this issue, but this lot expired on 31-Mar-2017 so Ortho took no action on this lot.
  • Product Description
    VITROS Immunodiagnostic Products TSH Reagent Pack