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Manufacturers
Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics, Inc.
제조사 모회사 (2017)
The Carlyle Group LP
Source
ANVSANVISA
10 Events
VANG VITROS REAGENT KIT Technical Name: VANCOMICINE ANVISA Registration Number: 80145900812 Hazard Class: II Affected Model: Box with 6 kits (Reagent 1: 9.7ml / Reagent 2: 4.9ml) Lot / Serial Numbers affected: SKU 6801709, lot 315506 의 안전성 경고
Product name: VITROS * DRY REACTIVE FOR SODIUM Technical Name: SODIUM ANVISA Registration Number: 10132590216 Hazard Class: II Affected Model: Box with 25 envelopes with 1 slide each / Box with 5 cartridges with 50 slides each Serial numbers affected: All VITROS Sodium Slides with SKU 8379034, generations 1 through 6, 30 through 40 and 44 through 49. Since this action affects all expired generations, in the validity and future generations, all customers with equipment compatible with the slides will be notified VITROS 250, VITROS 350, VITROS 5.1 FS, VITROS 4600 CHEMISTRY, VITROS 3600 IMMUNODIAGNOSTIC and VITROS 5600 INTEGRATED. 의 안전성 경고
VITROS Chemistry Products UPRO Slides, Product Code: 10132590346 Hazard Class: II Affected Model: 5 Cartridges with 18 Slides Serial Numbers Affected: VITROS Chemistry Products UPRO Slides, Product Code 6800120, Generations (GENs): 12, 13, 14, 15, 16, 17, 18. 의 안전성 경고
Ortho Vision Analyzer Technical Name: Immunohematology Equipment ANVISA Registration Number: 80145901739 Hazard Class: I Affected Model: Ortho Vision Analyzer Affected Series Numbers: ORTHO VISION® Cassette Analyzer ORTHO BioVue®, Product Code 6904579, Version of software 3.6.0 and earlier, Serial number 60002256 and 60002257. 의 안전성 경고
Commercial Name: Reactive Dry Vitros for ProteinC Reactive CRP / Dry Reactive Vitros for ProteinC Reactive CRP Technical Name: C Reactive Protein / Protein C Reagent ANVISA Registration Number: 10132590348 Hazard Class: II Affected Model: Box with 5 cartridges x 50 slides / Box with 5 cartridges x 18 slides Serial Numbers Affected: VITROS Chemistry Products PCR Slides; Product Codes: 1926740 and 8097990. Considering the scope of the affected lots (already distributed and possible commercialization), the list of customers using the inputs affected by this field action was considered based on the equipment purchased. 의 안전성 경고
VITROS * FOR PHENITOIN PHYT Technical Name: PHENYTOIN ANVISA Registration Number: 10132590219 Hazard Class: II Affected Model: VITROS * DRY REACTIVE FOR PHYTENIN PHENITOIN 5 cartridges with 18 slides VITROS Chemistry Products PHYT Slides , product code 8298671, lots: 1401566241, 1401566904, 1401577639, 1401578552, 1401578552, 1401580410, 1401589627, 1401591230, 1401592935, 1401604105 and 1401614738. The Assay Data Diskette (ADD) and Calibration 16607 products are not applicable. 의 안전성 경고
Product name: VITROS 4600 CHEMICAL SYSTEM / VITROS 5600 INTEGRATED SYSTEM Technical Name: Biochemical Analyzer / Biochemical Analyzer ANVISA Registration Number: 80145901335 Hazard Class: I Affected Model: Vitros 4600 Chemical (Viton 4600 / 5600 (R.Anvisa 80145901205) Serial numbers affected: VITROS® 4600 Chemistry System, Software Version 3.3, Product Code 6802445. VITROS® 5600 Integrated System, Software Version 3.3, Product Code 6802413 and 6802915. 의 안전성 경고
VITROS® Chemistry Products Calibrator Kit 9, Lot SKU 8568040 - 0954 의 안전성 경고
VITROS 5.1 FUSION Chemical System, Registration No. 80145900827 and VITROS 4600 and 5600 Chemical System, Registration No. 80145901335, lots / Serial No .: See Annex 1 - Distribution List. 의 안전성 경고
CHEMICAL SYSTEM VITROS 5,1 FUSION, Registration no. 80145900827, lots: See Annex 1 - Distribution list. 의 안전성 경고
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데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 10 건
VANG VITROS REAGENT KIT Technical Name: VANCOMICINE ANVISA Registration Number: 80145900812 Hazar...
모델명 / 제조번호(시리얼번호)
Product name: VITROS * DRY REACTIVE FOR SODIUM Technical Name: SODIUM ANVISA Registration Number:...
모델명 / 제조번호(시리얼번호)
VITROS Chemistry Products UPRO Slides, Product Code: 10132590346 Hazard Class: II Affected Model:...
모델명 / 제조번호(시리얼번호)
Ortho Vision Analyzer Technical Name: Immunohematology Equipment ANVISA Registration Number: 8014...
모델명 / 제조번호(시리얼번호)
Commercial Name: Reactive Dry Vitros for ProteinC Reactive CRP / Dry Reactive Vitros for ProteinC...
모델명 / 제조번호(시리얼번호)
하나 더 5 건 더
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