Vitros immunodiagnostic products TSH reagent pack

4 devices with a similar name

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  • Model / Serial
    Lot 5040 (Expiry date 19 Dec 2016)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US to VA, WV, GA, TN, KY, MN, SD, AR, OK and Internationally to Canada
  • Product Description
    VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK || For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
  • Manufacturer
  • 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
  • Manufacturer
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ortho Clinical Diagnostics VITROS Immunodiagnostic Products TSH Calibrators; VITROS Immunodiagnostic Products TSH Reagent Packs
  • Manufacturer
  • Model / Serial
  • Product Description
    Ortho VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2; Ortho-Clinical ECI Immunodiagnostics Products PSA Reagent Pack/Calibrator; Ortho VITROS Immunodiagnostic Products FSH Reagent Pack; Ortho VITROS Immunodiagnostic Products Prolactin Reagent Pack; Ortho-Clinical VITROS Immunodiagnostic Products TSH Reagent Pack, Ortho Clinical Diagnostics
  • Manufacturer