Atlas FDA

VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1

FDA 510(k) clearance K031924 · decided 2003-08-07

Clearance details

K-number
K031924
Device name
VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1
Applicant
Ortho-Clinical Diagnostics
Decision
Substantially Equivalent
Date received
2003-06-23
Decision date
2003-08-07
Days to decision
45 days
Clearance type
Traditional
Product code
JIT
Device class
2
Regulation number
862.1150
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 4600 Chemistry System Model/Catalog Number: (1) 68 recall (Z-2040-2025)Ortho-Clinical Diagnostics, Inc.2025-06-27
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished) recall (Z-1225-2024)Ortho-Clinical Diagnostics, Inc.2024-03-01
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished) recall (Z-1230-2024)Ortho-Clinical Diagnostics, Inc.2024-03-01
VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Run recall (Z-0544-2024)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 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 1075 recall (Z-1073-2016)Ortho-Clinical Diagnostics2016-03-08
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10 recall (Z-1075-2016)Ortho-Clinical Diagnostics2016-03-08
VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 1075 recall (Z-0642-2016)Ortho-Clinical Diagnostics2016-01-13
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10 recall (Z-0643-2016)Ortho-Clinical Diagnostics2016-01-13
VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identif recall (Z-0231-2016)Ortho-Clinical Diagnostics2015-11-05
VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identif recall (Z-2544-2015)Ortho-Clinical Diagnostics2015-09-02
Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, G recall (Z-1521-2015)Ortho-Clinical Diagnostics2015-04-25
VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems ( recall (Z-1004-2015)Ortho-Clinical Diagnostics2015-01-20
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 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 680 recall (Z-0077-2015)Ortho-Clinical Diagnostics2014-10-16
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chem recall (Z-2140-2014)Ortho-Clinical Diagnostics2014-08-01
VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic recall (Z-1734-2014)Ortho-Clinical Diagnostics2014-06-09
VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Number recall (Z-1736-2014)Ortho-Clinical Diagnostics2014-06-09
1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry Sy recall (Z-1647-2013)Ortho-Clinical Diagnostics2013-07-02
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Pr recall (Z-1648-2013)Ortho-Clinical Diagnostics2013-07-02
VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Re recall (Z-1106-2013)Ortho-Clinical Diagnostics2013-04-13
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. I recall (Z-1107-2013)Ortho-Clinical Diagnostics2013-04-13
VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and recall (Z-2066-2012)Ortho-Clinical Diagnostics2012-07-23
VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitat recall (Z-2067-2012)Ortho-Clinical Diagnostics2012-07-23
VITROS® 4600 Chemistry System, Product Code: 6802445 Product Usage: Fo recall (Z-1469-2012)Ortho-Clinical Diagnostics2012-04-26
VITROS 5,1 FS (Fusion Series) Chemistry System Software Version 2.2.1, only when using VIT recall (Z-1167-2007)Ortho-Clinical Diagnostics2007-08-16

PMA approvals by this applicant

RecordFirmDate
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S017)Ortho-Clinical Diagnostics2023-01-24
VITROS Anti-HBe (P100001/S016)Ortho-Clinical Diagnostics2019-06-19
VITROS Anti-HBc (P030024/S029)Ortho-Clinical Diagnostics2019-06-19
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S028)Ortho-Clinical Diagnostics2018-12-17
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S015)Ortho-Clinical Diagnostics2018-12-17
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S027)Ortho-Clinical Diagnostics2018-10-16
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S025)Ortho-Clinical Diagnostics2018-07-02
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S026)Ortho-Clinical Diagnostics2018-07-02