Atlas FDA

VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM

FDA 510(k) clearance K081543 · decided 2008-10-23

Clearance details

K-number
K081543
Device name
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM
Applicant
Ortho-Clinical Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2008-06-02
Decision date
2008-10-23
Days to decision
143 days
Clearance type
Special
Product code
JLW
Device class
2
Regulation number
862.1690
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Rochester, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6 recall (Z-2038-2025)Ortho-Clinical Diagnostics, Inc.2025-06-27
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 68024 recall (Z-1005-2025)Ortho-Clinical Diagnostics, INc.2025-01-21
VITROS 5600 Integrated System (New and Refurbished) recall (Z-1221-2024)Ortho-Clinical Diagnostics, Inc.2024-03-01
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished) recall (Z-1226-2024)Ortho-Clinical Diagnostics, Inc.2024-03-01
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished) recall (Z-1231-2024)Ortho-Clinical Diagnostics, Inc.2024-03-01
VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Ru recall (Z-0545-2024)Ortho-Clinical Diagnostics, Inc.2023-12-13
Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product recall (Z-0008-2024)Ortho-Clinical Diagnostics, Inc.2023-10-02
VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, an recall (Z-1556-2023)Ortho-Clinical Diagnostics, Inc.2023-05-04
VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-q recall (Z-1557-2023)Ortho-Clinical Diagnostics, Inc.2023-05-04
VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 1075 recall (Z-1074-2016)Ortho-Clinical Diagnostics2016-03-08
VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 1075 recall (Z-0641-2016)Ortho-Clinical Diagnostics2016-01-13
VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique recall (Z-0202-2016)Ortho-Clinical Diagnostics2015-11-02
VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and p recall (Z-1742-2015)Ortho-Clinical Diagnostics2015-06-09
VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and p recall (Z-1743-2015)Ortho-Clinical Diagnostics2015-06-09
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagno recall (Z-0967-2015)Ortho-Clinical Diagnostics2015-01-14
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, recall (Z-0968-2015)Ortho-Clinical Diagnostics2015-01-14
VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. recall (Z-0969-2015)Ortho-Clinical Diagnostics2015-01-14
VITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro quanti recall (Z-0078-2015)Ortho-Clinical Diagnostics2014-10-16
VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-quantitative, recall (Z-2141-2014)Ortho-Clinical Diagnostics2014-08-01
VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic recall (Z-1735-2014)Ortho-Clinical Diagnostics2014-06-09
VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671 VI recall (Z-0321-2014)Ortho-Clinical Diagnostics2013-11-15
VITROS 5600 Integrated System (product code 6802413) Product Usage: For use in the in vitr recall (Z-1649-2013)Ortho-Clinical Diagnostics2013-07-02
VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement o recall (Z-1108-2013)Ortho-Clinical Diagnostics2013-04-13
VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi quantita recall (Z-2068-2012)Ortho-Clinical Diagnostics2012-07-23
VITROS 5600 Integrated System Software Version 1.6 & Below Product Usage: For use in the i recall (Z-1699-2012)Ortho-Clinical Diagnostics2012-06-01
VITROS® 5600 Chemistry System, Product Code: 6802413 Product Usage: Fo recall (Z-1470-2012)Ortho-Clinical Diagnostics2012-04-26

PMA approvals by this applicant

RecordFirmDate
VITROS Anti-HBc IgM (P030026/S037)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S018)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S036)Ortho-Clinical Diagnostics, Inc.2020-10-22
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S033)Ortho-Clinical Diagnostics, Inc.2020-08-07
VITROS Anti-HBs (P000014/S035)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S032)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Anti-HBc IgM (P030026/S036)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS HBeAg (P090028/S017)Ortho-Clinical Diagnostics, Inc.2019-06-19