Roche Diagnostics Operations Inc.

Entity profile compiled from public source records

Public Record Profile Registrations: 14 510(k) filings: 0 Recalls: 3

Known Identifiers & Locations

FEI Numbers 1000125183, 1823260, 2243471, 3002806559, 3002806560, 3003618481, 3003795116, 3004141078, 3009731198, 3010900203, 3011393376, 3011806823, 3020917535, 3039321686, 3039322300
Owner Operator Numbers 9039767
Locations Covered Bathgate Scotland, GB; Branchburg, NJ, US; Indianapolis, IN, US; Ludwigsburg Baden-Wurttemberg, DE; MANNHEIM Baden-Wurttemberg, DE; Mannheim Baden-Wurttemberg, DE; Manor Loan Stirling, GB; PENZBERG Bavaria, DE; PLEASANTON, CA, US; ROTKREUZ Zug, CH; Sant Cugat del Valles Barcelona, ES; Santa Clara, CA, US; Suzhou Jiangsu, CN; Tucson, AZ, US

Registered Establishments (14)

Registration # Establishment Name Location Establishment Type(s) Action
2028492 VENTANA MEDICAL SYSTEMS, INC. Tucson, AZ, US Manufacture Medical Device View Details
2243471 ROCHE MOLECULAR SYSTEMS, INC. Branchburg, NJ, US Manufacture Medical Device View Details
3003618481 Roche Diagnostics Automation Solutions GmbH Ludwigsburg Baden-Wurttemberg, DE Manufacture Medical Device View Details
3003795116 ROCHE DIAGNOSTICS INTERNATIONAL LTD. ROTKREUZ Zug, CH Manufacture Medical Device View Details
3004141078 ROCHE MOLECULAR SYSTEMS, INC. PLEASANTON, CA, US Develop Specifications But Do Not Manufacture At This Facility View Details
3009731198 Roche Diagnostics Santa Clara Santa Clara, CA, US Manufacture Medical Device View Details
3010900203 Roche Diagnostics S.L. Sant Cugat del Valles Barcelona, ES Develop Specifications But Do Not Manufacture At This Facility View Details
3011393376 ROCHE DIABETES CARE, INC. Indianapolis, IN, US Manufacture Device in the United States for Export Only View Details
3011806823 Roche Diabetes Care GmbH Mannheim Baden-Wurttemberg, DE Manufacture Medical Device View Details
3020917535 Roche Diagnostics (Suzhou) Ltd. Suzhou Jiangsu, CN Manufacture Medical Device View Details
3039321686 Roche Lumira Dx Stirling Manor Loan Stirling, GB Manufacture Medical Device View Details
3039322300 Roche Lumira Dx Bathgate Bathgate Scotland, GB Manufacture Medical Device View Details
9610126 ROCHE DIAGNOSTICS GMBH MANNHEIM Baden-Wurttemberg, DE Repack or Relabel Medical Device,Manufacture Medical Device View Details
9610529 ROCHE DIAGNOSTICS GMBH PENZBERG Bavaria, DE Manufacture Medical Device View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (3)

Recall # Product Description Initiation Date Status Action
Z-0042-2020 Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502 Reason: Inaccurately Low Sample Results 2019-07-23 Terminated View Details
Z-0043-2020 Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502 Reason: Inaccurately Low Sample Results 2019-07-23 Terminated View Details
Z-0044-2020 AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001 Reason: AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an Abnormal Internal Structure and lead to Incorrect patient results 2019-08-13 Terminated View Details

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