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Ortho-Clinical Diagnostics

162 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
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 5600 Integrated System (product code 6802413) Product Usage: For use in the in vitr recall (Z-1649-2013)Ortho-Clinical Diagnostics2013-07-02
VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the i recall (Z-1650-2013)Ortho-Clinical Diagnostics2013-07-02
ORTHO Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO Summit System (OSS) recall (Z-1651-2013)Ortho-Clinical Diagnostics2013-07-02
VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Pr recall (Z-1614-2013)Ortho-Clinical Diagnostics2013-06-27
VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, recall (Z-1615-2013)Ortho-Clinical Diagnostics2013-06-27
VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to recall (Z-1556-2013)Ortho-Clinical Diagnostics2013-06-19
VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diag recall (Z-1337-2013)Ortho-Clinical Diagnostics2013-05-17
VITROS Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen ( recall (Z-1161-2013)Ortho-Clinical Diagnostics2013-04-23
VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative recall (Z-1152-2013)Ortho-Clinical Diagnostics2013-04-19
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 5600 Integrated System, Product Code 6802413. Intended for use in the measurement o recall (Z-1108-2013)Ortho-Clinical Diagnostics2013-04-13
Ortho Clinical Diagnostics VITROS Chemistry Products Vapor Adsorption Cartridge REF/CAT No recall (Z-0755-2013)Ortho-Clinical Diagnostics2013-01-30
VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box wit recall (Z-2211-2012)Ortho-Clinical Diagnostics2012-08-15
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 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® 3600 Immunodiagnostic System Product Usage: For use in the in recall (Z-1468-2012)Ortho-Clinical Diagnostics2012-04-26
VITROS® 4600 Chemistry System, Product Code: 6802445 Product Usage: Fo recall (Z-1469-2012)Ortho-Clinical Diagnostics2012-04-26
VITROS® 5600 Chemistry System, Product Code: 6802413 Product Usage: Fo recall (Z-1470-2012)Ortho-Clinical Diagnostics2012-04-26
VITROS® 5,1 FS System, Product Codes: 6801375 & 68 recall (Z-1471-2012)Ortho-Clinical Diagnostics2012-04-26
VITROS® 5,1 FS Refurbished System, Product Codes: 6801375 &amp recall (Z-1472-2012)Ortho-Clinical Diagnostics2012-04-26
VITROS Chemistry Products --- dHDL Slides --- Ortho Clinical Diagnostics, a Johnson&Johnso recall (Z-1316-2012)Ortho-Clinical Diagnostics2012-03-26
VITROS Chemistry Products --- ALT Slides --- [REF] 165 5281 --- [Mfg Symbol] Ortho-Clinica recall (Z-1277-2012)Ortho-Clinical Diagnostics2012-03-22
VITROS Chemistry Products PHBR Slides, REF 822 1384 --- COMMON/USUAL NAME: VITROS PHBR (Ph recall (Z-1117-2012)Ortho-Clinical Diagnostics2012-02-28
VITROS 3600 Immunodiagnostics Systems, Catalog # 6802783; COMMON/USUAL NAME: VITROS 3600 - recall (Z-1072-2012)Ortho-Clinical Diagnostics2012-02-21
VITROS 5600 Integrated Systems, Catalog # 6802413; COMMON/USUAL NAME: VITROS 5600 --- NOTE recall (Z-1073-2012)Ortho-Clinical Diagnostics2012-02-21
VITROS Valproic Acid (VALP) Reagent, REF/Catalog No. 6801710 --- Ortho- Clinical Diagnosti recall (Z-0984-2012)Ortho-Clinical Diagnostics2012-02-08
VITROS Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name: VITR recall (Z-0971-2012)Ortho-Clinical Diagnostics2012-02-07
VITROS Chemistry Products DT Calibrator Kit, REF/Catalog No. 195 7927, IVD --- Common/Usua recall (Z-0917-2012)Ortho-Clinical Diagnostics2012-01-27
VITROS ECi Immunodiagnostic System, Catalog No. 8633893 --- COMMON/USUAL NAME: VITROS ECi recall (Z-0923-2012)Ortho-Clinical Diagnostics2012-01-27
VITROS ECiQ Immunodiagnostic System, Catalog No. 1922814 --- COMMON/USUAL NAME: VITROS ECi recall (Z-0924-2012)Ortho-Clinical Diagnostics2012-01-27
enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Cen recall (Z-0914-2012)Ortho-Clinical Diagnostics2012-01-26
VITROS Chemistry Products Calibrator Kit 16, REF 680 1700, 5x1 mL --- Ortho-Clinical Diagn recall (Z-0714-2012)Ortho-Clinical Diagnostics2012-01-11
The enGenTM Laboratory Automation System consists of 3 main components including Instrumen recall (Z-1831-2011)Ortho-Clinical Diagnostics2011-03-28
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
VITROS Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Trop recall (Z-0820-2007)Ortho-Clinical Diagnostics2007-05-26
VITROS Immunodiagnostics Products HBsAg Reagent Pack, Catalog # 6801322: 1 Reagent Pack bo recall (Z-0747-2007)Ortho-Clinical Diagnostics2007-04-14
VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 s recall (Z-0245-2007)Ortho-Clinical Diagnostics2006-12-05
VITROS Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per bo recall (Z-0151-2007)Ortho-Clinical Diagnostics2006-11-04
VITROS WorkCentre, Catalog # 6802159, using enGen" Series Automation Systems (Catalog # EN recall (Z-0077-2007)Ortho-Clinical Diagnostics2006-10-27
VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diag recall (Z-0765-06)Ortho-Clinical Diagnostics2006-04-20
Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324. Firm on label: Ortho-Clinic recall (Z-0327-06)Ortho-Clinical Diagnostics2006-01-06
VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostic recall (Z-0173-06)Ortho-Clinical Diagnostics2005-11-18
Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), recall (Z-0137-06)Ortho-Clinical Diagnostics2005-11-15
VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical recall (Z-1460-05)Ortho-Clinical Diagnostics2005-09-01
Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diag recall (Z-1016-05)Ortho-Clinical Diagnostics2005-07-16
VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. F recall (Z-0913-05)Ortho-Clinical Diagnostics2005-06-21
VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid r recall (Z-0866-05)Ortho-Clinical Diagnostics2005-06-04
Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog #80 recall (Z-0387-05)Ortho-Clinical Diagnostics2005-01-08
VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slid recall (Z-1473-04)Ortho-Clinical Diagnostics2004-09-18
Vitros Immunodiagnostic Products TROPONIN I Reagent Packs, (Lot 1110 and 1130 REF #194 988 recall (Z-1053-04)Ortho-Clinical Diagnostics2004-07-20
Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pa recall (Z-0298-04)Ortho-Clinical Diagnostics2004-01-06
Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells recall (Z-0299-04)Ortho-Clinical Diagnostics2004-01-06
Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for a recall (Z-1224-03)Ortho-Clinical Diagnostics2003-09-11
Vitros Chemistry *** GLU (glucose) DT Slides ***25 slides per box *** CAT 153 2316 *** Ort recall (Z-1225-03)Ortho-Clinical Diagnostics2003-09-11
Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein conc recall (Z-0919-03)Ortho-Clinical Diagnostics2003-06-05
CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 recall (Z-0557-03)Ortho-Clinical Diagnostics2003-02-21
Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic us recall (Z-0558-03)Ortho-Clinical Diagnostics2003-02-21
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