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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 901–920 of 970 recalls

Roche Diagnostics Corp.: MagNA Pure LC Instrument; catalog numbers 2236931 and 036...

A hardware/software problem will result in low elution volumes and bias sample results for various protocols.

FDAAug 6, 2004Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche/Hitachi 747 - 100 clinical chemistry analyzer; cata...

A software defect will allow the reporting out of believable, but clinically significant, erroneous results if the analyzer is in operation and a channel has been masked or not requested over a period of time.

FDAAug 6, 2004Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche/Hitachi 747 - 200 clinical chemistry analyzer; cata...

A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.

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FDA

Aug 6, 2004

Nationwide

• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche/Hitachi Modular Additional D Module DAT clinical ch...

A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.

FDAAug 6, 2004Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche/Hitachi Modular Analytical D Module clinical chemis...

A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.

FDAAug 6, 2004Nationwide• Roche Diagnostics Corp.

Ortho-Clinical Diagnostics: VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box...

The Immuno-rate (IR) wash detection algorithm may result in inappropriate wash detections.

FDAJul 28, 2004Nationwide• Ortho-Clinical Diagnostics

Abbott Laboratories Diagnostic Div: Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creati...

Precipitate formed in product.

FDAJul 27, 2004Nationwide• Abbott Laboratories Diagnostic Div

Roche Diagnostics Corp.: Roche brand Reflotron GOT (AST), 30 test strips; catalog ...

Coating defect may result is falsely decreased patient and/or control results.

FDAJul 14, 2004Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand Reflotron GPT (ALT) 30 test strips; catalog #...

Coating defect may result is falsely decreased patient and/or control results.

FDAJul 14, 2004Nationwide• Roche Diagnostics Corp.

Fisher Diagnostic, A Company of Fisher Scientific LLC: Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics ...

Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples.

FDAJul 1, 2004Nationwide• Fisher Diagnostic, A Company of Fisher Scientific LLC

Nichols Institute Diagnostics: Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog num...

Lower than expected results are obtained.

FDAJun 30, 2004Nationwide• Nichols Institute Diagnostics

Roche Diagnostics Corp.: ACCU-CHEK Inform meter; catalog No. 3035123.

Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.

FDAJun 30, 2004Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: ACCU-CHEK Inform base unit; catalog no. 3035131.

Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.

FDAJun 30, 2004Nationwide• Roche Diagnostics Corp.

ABX Diagnostics Inc: PENTRA 120 and PENTRA 120 Retic Hematology Analyzer

Power failure having impact on software.

FDAJun 24, 2004Nationwide• ABX Diagnostics Inc

Roche Diagnostics Corp.: Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit...

May report falsely decreased patient results.

FDAJun 18, 2004Nationwide• Roche Diagnostics Corp.

Ortho-Clinical Diagnostics: Vitros Immunodiagnostic Products TROPONIN I Reagent Packs...

Random occurrence of false positive test results.

FDAJun 7, 2004Nationwide• Ortho-Clinical Diagnostics

Roche Diagnostics Corp.: Disetronic brand 5 ml. glass cartridges used with the Pan...

Lack of assurance of sterility.

FDAMay 17, 2004Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Disetronic brand 3.15 ml glass cartridges used with H-tro...

Lack of assurance of sterility.

FDAMay 17, 2004Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Tecan clinical workstation; 10-410 Tecan Genesis 150 back...

Tecan software has the potential to match the patient with a different patient's test results.

FDAMay 5, 2004Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: COBAS Gui software interface between the Cobas AMPLICOR i...

The Roche COBAS interface driver for the Tecan software may assign sample results to the wrong patient.

FDAMay 5, 2004CA, CT, IL +4 more• Roche Diagnostics Corp.