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Roche Diagnostics Corp.

Roche Diagnostics Corp. Recalls

All product recalls associated with Roche Diagnostics Corp..

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Recall Summary

Total Recalls

970

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 941–960 of 970 recalls

Roche Diagnostics Corp.: Roche brand OMNI 7 clinical chemistry analyzer; catalog n...

If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.

FDADec 15, 2003Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand OMNI 9 clinical chemistry analyzer; catalog n...

If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.

FDADec 15, 2003Nationwide• Roche Diagnostics Corp.

Ortho-Clinical Diagnostics: Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 75...

Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.

1...46 474849

Page 48 of 49Next

FDA

Dec 3, 2003

IN, PR

• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF ...

Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.

FDANov 26, 2003Nationwide• Ortho-Clinical Diagnostics

Abbott Laboratories Diagnostic Div: AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7...

False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN.

FDANov 24, 2003Nationwide• Abbott Laboratories Diagnostic Div

Abbott Laboratories Diagnostic Div: Clinical Chemistry Urea Nitrogen

Low results due to contaminant.

FDANov 24, 2003Nationwide• Abbott Laboratories Diagnostic Div

Abbott Laboratories Diagnostic Div: AEROSET Phenobarbital, LN 1E08-01

Assay is imprecise.

FDANov 3, 2003Nationwide• Abbott Laboratories Diagnostic Div

Roche Diagnostics Corp.: CoaguChek brand PT Test Strips; U.S. catalog number 31162...

Erroneous patient results: may be falsely elevated or lowered, due to a packaging defect that allows air and moisture to enter the sealed pouch.

FDASep 12, 2003Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche/Hitachi brand lactate reagent for the quantitative ...

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.

FDASep 2, 2003Nationwide• Roche Diagnostics Corp.

Watson Diagnostics Inc.: Papsure, Speculite, Disposable light for vaginal illumina...

Lights split, spilling contents when bent to activate.

FDAAug 7, 2003Nationwide• Watson Diagnostics Inc.

Diagnostic Products Corp: Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test...

Kits had parts in them that did not belong in the kit.

FDAJul 31, 2003Nationwide• Diagnostic Products Corp

Ortho-Clinical Diagnostics: Vitros Chemistry * GLU (glucose) Slides * 5 cartridge...

Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator. GLU slides are processed by high volume chemistry systems typically used in hospital laboratories.

FDAJul 28, 2003Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: Vitros Chemistry * GLU (glucose) DT Slides *25 slides...

Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator.

FDAJul 28, 2003Nationwide• Ortho-Clinical Diagnostics

Roche Diagnostics Corp.: Disetronic Dahedi insulin infusion pump; catalog # 8500019.

Lack of assurance of reliability.

FDAJul 28, 2003Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Disetronic D-TRONplus Insulin Pump

Lack of assurance of reliability and notice to D-tron+ users to examine pump keys for punctures, not to use pumps with punctured keys near water, and to alert users to the possibility of a sticking piston rod.

FDAJul 24, 2003Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Disetronic H-TRON V100 Insulin Pump; catalog # 8010030C [...

Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.

FDAJul 21, 2003Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [cl...

Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.

FDAJul 21, 2003Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: MagNA Pure LC Instrument; Catalog number 2236931.

A software bug in version 3.0 may result in prolonged mixing time, evaporation of elution volume and biased sample results for various protocols.

FDAJun 26, 2003Nationwide• Roche Diagnostics Corp.

Bayer HealthCare LLC, Diagnostics Div: Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C...

Analyzer will produce erroneous results due to missing grounding strap.

FDAJun 19, 2003Nationwide• Bayer HealthCare LLC, Diagnostics Div

ABX Diagnostics Inc: ABX Diagnostices Pentra 60C+ Hematology Analyzer

Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door.

FDAJun 4, 2003Nationwide• ABX Diagnostics Inc