Roche Diagnostics Corp.

Entity profile compiled from public source records

Public Record Profile Registrations: 0 510(k) filings: 3 Recalls: 9

Known Identifiers & Locations

FEI Numbers 1823260
Owner Operator Numbers N/A
Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (3)

Submission # Device Name Decision Date Decision Description Action
K013373 OMNI C ANALYZER 2001-11-02 Substantially Equivalent View Details
K060586 ENZYME IMMUNOASSAY, VANCOMYCIN 2006-05-11 Substantially Equivalent View Details
K060755 ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK 2006-04-10 Substantially Equivalent View Details

FDA Recall History (9)

Recall # Product Description Initiation Date Status Action
Z-0006-2009 Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03038866322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol concentrations in serum and plasma. Reason: Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. 2008-06-11 Terminated View Details
Z-0007-2009 Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03183696122. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of iron in serum and plasma. Reason: Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. 2008-06-11 Terminated View Details
Z-0008-2009 Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03263991190. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of creatine in serum, urine and plasma. Reason: Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. 2008-06-11 Terminated View Details
Z-0009-2009 Roche Diagnostics STFR Tina-quant Soluble Transferrin Receptor, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 20763454122. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of soluable transferrin receptor in serum and plasma. Reason: Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. 2008-06-11 Terminated View Details
Z-0010-2009 Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04399803190. An in-vitro diagnostic reagent system intended for use on COMAS Integra systems for the quantitative determination of HDL-cholesterol in serum and plasma. Reason: Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. 2008-06-11 Terminated View Details
Z-0011-2009 Roche Diagnostics ALBT2, Tina-quant Albumin Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04469658190. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of albumin concentration in serum and plasma. Reason: Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. 2008-06-11 Terminated View Details
Z-0012-04 Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156. Reason: Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the R1 reagent is depleted. 2003-05-08 Terminated View Details
Z-0012-2009 Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.; 20737852322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the qualitative determination of NAPA in serum or plasma. Reason: Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. 2008-06-11 Terminated View Details
Z-0028-04 Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837. Reason: Patient samples with very high lactate values may falsely be reported as within the normal range without the instrument giving a warning flag to the technician. 2003-09-02 Terminated View Details

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