Devices

Name Classification Manufacturer Risk Class Country Source
VITROS Clinical Chemistry Products Homocysteine (HCY) Reagent Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 2 United States
Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324. Firm on label: Ortho-Clinical Diagnostics, 62 The Broadway, Amersham, Bucks, UK. UPC *+H221680132412* . Each kit contains: 1 x kit of reagents, and protocol card for HBsAg Confirmatory Kit. According to the firm (but not on label), there are 60 neutralization reactions per confirmatory kit. Immunology and Microbiology Devices Ortho-Clinical Diagnostics 3 United States
VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc., Rochester, NY 14626. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 2 United States
Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 2 United States
VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK. Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 2 United States
Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog #809 7990 contains 90 slides. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company, Rochester, NY 14626. Immunology and Microbiology Devices Ortho-Clinical Diagnostics 2 United States
VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. The CRP Slides are for use on the Vitros 250/250AT and/or Vitros 950/950AT Clinical Chemistry Systems. For in vitro diagnostic use. Vitros CRP slides quantitatively measure C-reactive protein concentration in serum and plasma. Immunology and Microbiology Devices Ortho-Clinical Diagnostics 2 United States
Device Recall enGen (TM) Laboratory Automation Systems Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 1 United States
Device Recall VITROS Chemistry Products VANC Reagent Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 2 United States
Device Recall VITROS Chemistry Products Li Slides Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 2 United States
Device Recall VITROS Immunodiagnostic HBsAg Controls Immunology and Microbiology Devices Ortho-Clinical Diagnostics 1 United States
Device Recall enGen Laboratory Automation System Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 1 United States
Device Recall enGen(TM) Laboratory Automation System Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 1 United States
Device Recall VITROS Immunodiagnostic Products Total BetahCG II Reagent Pack Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 2 United States
Device Recall VITROS 5600 Integrated System Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 1 United States
Device Recall VITROS 5,1 FS Chemistry System Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 1 United States
Device Recall VITROS 5600 Chemistry System Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 1 United States
Device Recall VITROS 4600 Chemistry System Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 1 United States
Device Recall VITROS 350 Chemistry System Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 1 United States
Device Recall VITROS 250 Chemistry System Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 1 United States
Device Recall VITROS 5,1 FS Chemistry System Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 1 United States
Device Recall VITROS 4600 Chemistry System Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 1 United States
Device Recall VITROS 5600 Chemistry System Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 1 United States
Device Recall VITROS 3600 Chemistry System Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 1 United States
Device Recall VITROS 5,1 FS Chemistry System Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 1 United States