Ortho-Clinical Diagnostics
Ortho-Clinical Diagnostics holds FDA 510(k) medical device clearances, first cleared 1999, most recent 2024, with 221 FDA device recalls on record.
Name variants for Ortho-Clinical Diagnostics
as filed with FDA- Ortho-Clinical Diagnostics
- Ortho Clinical Diagnostics
Top product codes for Ortho-Clinical Diagnostics
FDA recalls by Ortho-Clinical Diagnostics
10 most recent of 221- Z-1372-2024 — VITROS Performance Verifier I
- Z-1373-2024 — VITROS Performance Verifier II
- Z-2358-2023 — VITROS Immunodiagnostic Products Troponin I ES Calibrators
- Z-2357-2023 — VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
- Z-2129-2023 — VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM. Product Code: 6801704
- Z-2879-2020 — VITROS XT7600 Integrated System, Product code 6844461
- Z-2878-2020 — VITROS XT3400 Chemistry System, Product code 6844458
- Z-2771-2020 — VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
- Z-2770-2020 — VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
- Z-2875-2020 — VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Ortho-Clinical Diagnostics
- K241534 — VITROS Immunodiagnostic Products Syphilis Reagent Pack
- K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
- K221197 — VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
- K231517 — VITROS Immunodiagnostic Products CEA Reagent Pack
- K231525 — VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
- K221355 — VITROS Immuodiagnostic Products CA 125 II Reagent Pack
- K213626 — VITROS AFP
- K212648 — VITROS Immunodiagnostic Products CK-MB Reagent Pack
- K201312 — VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
- K200236 — VITROS BRAHMS PCT Reagent Pack and Calibrators
- K163433 — VITROS Chemistry Products GLU Slides
- K160712 — VITROS Chemistry Products hsCRP Reagent
- K171168 — VITROS Immunodiagnostic Products Insulin Calibrators
- K162020 — VITROS Chemistry Products Cl- Slides
- K152433 — VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7
- K142595 — VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II
- K101921 — VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT
- K083173 — VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM
- K063720 — VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS
- K062165 — VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS
- K062838 — VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303
- K060480 — VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS
- K052645 — VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873
- K042494 — VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III
- K042303 — VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
- K041764 — THE VITROS 5,1 FS CHEMISTRY SYSTEM
- K033127 — VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS
- K031924 — VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1
- K024193 — MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS
- K030067 — VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
- K022901 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS
- K020662 — MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS
- K013899 — VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS
- K013900 — VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS
- K012561 — VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS
- K011463 — VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS
- K001769 — VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT
- K993068 — VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS
Data sourced from openFDA. This site is unofficial and independent of the FDA.