Chrysalis Intelligence · Sponsors · Ortho Clinical Diagnostics

Ortho Clinical Diagnostics

Bridgend, GB · 10 510(k) clearances · 17 recalls

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Total clearances
10
2020-02-25 → 2024-08-28
Last 12 months
0
Product codes
10
Most recent
2024-08-28
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LIP — — — 1 2024-08-28
DHA System, Test, Human Chorionic Gonadotropin Class II Clinical Chemistry 1 2024-05-08
CEW Radioimmunoassay, Parathyroid Hormone Class II Clinical Chemistry 1 2023-09-05
DHX System, Test, Carcinoembryonic Antigen Class II Immunology 1 2023-08-23
NIG — — — 1 2023-08-09
LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) Class II Immunology 1 2022-12-12
LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer Class II Immunology 1 2022-06-15
JHX Fluorometric Method, Cpk Or Isoenzymes Class II Clinical Chemistry 1 2022-01-28
NBC — — — 1 2021-10-04
PMT Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens Class II Microbiology 1 2020-02-25
Safety

Recalls (17)

Class I (serious)
0
Risk of injury / death
Total recalls
17
Currently ongoing
2
Most recent
2021-09-10
DateSeverityStatusRecall # ProductCodeReason
2021-09-10 Class II Terminated Z-0120-2022 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance… — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results
2020-12-15 Class II Terminated Z-0845-2021 VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concen… — Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
2020-12-15 Class II Terminated Z-0844-2021 VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/3… — Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
2020-12-11 Class II Ongoing Z-0770-2021 VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS… — VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference
2020-10-16 Class III Ongoing Z-0471-2021 VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance… — Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatu…
2020-09-30 Class II Terminated Z-0451-2021 VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of … — Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased si…
2020-09-30 Class II Terminated Z-0450-2021 VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identify… — Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased si…
2020-07-20 Class II Terminated Z-2879-2020 VITROS XT7600 Integrated System, Product code 6844461 — When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous re…
2020-07-20 Class II Terminated Z-2878-2020 VITROS XT3400 Chemistry System, Product code 6844458 — When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous re…
2020-07-17 Class II Terminated Z-2771-2020 VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usa… — The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality …
2020-07-17 Class II Terminated Z-2770-2020 VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage:… — The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality …
2020-05-20 Class II Terminated Z-2484-2020 VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758… — Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
2020-05-20 Class II Terminated Z-2483-2020 VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifi… — Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
2020-05-20 Class II Terminated Z-2482-2020 VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 1075875000… — Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
2020-05-20 Class II Terminated Z-2481-2020 VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103 — Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
2020-05-20 Class II Terminated Z-2480-2020 VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 1075875… — Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
2020-03-10 Class III Terminated Z-1834-2020 VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468 — The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
Filings

All 510(k) clearances (10)

Date K-number Device Code Class Specialty
2024-08-28 K241534 VITROS Immunodiagnostic Products Syphilis Reagent Pack LIP — —
2024-05-08 K233581 VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack DHA Class II Clinical Chemistry
2023-09-05 K221197 VITROS Immunodiagnostic Products Intact PTH II Reagent Pack CEW Class II Clinical Chemistry
2023-08-23 K231517 VITROS Immunodiagnostic Products CEA Reagent Pack DHX Class II Immunology
2023-08-09 K231525 VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack NIG — —
2022-12-12 K221355 VITROS Immuodiagnostic Products CA 125 II Reagent Pack LTK Class II Immunology
2022-06-15 K213626 VITROS AFP LOJ Class II Immunology
2022-01-28 K212648 VITROS Immunodiagnostic Products CK-MB Reagent Pack JHX Class II Clinical Chemistry
2021-10-04 K201312 VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack NBC — —
2020-02-25 K200236 VITROS BRAHMS PCT Reagent Pack and Calibrators PMT Class II Microbiology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence