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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

46

Class I (Serious)

16

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 921–940 of 970 recalls

Roche Diagnostics Corp.: Tecan clinical workstation; Tecan Genesis 150/8 front end...

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

FDAMay 5, 2004Nationwide• Roche Diagnostics Corp.

Diagnostic Products Corp: Immulite 1000 CEA Catalog No. LKCE1

Instabililty

FDAMay 3, 2004Nationwide• Diagnostic Products Corp

ABX Diagnostics Inc: Pentra 80 and Pentra 80XL Hematology Analyzers

Software defect, instrument may erroneously give a result of '0' or '---'.

FDAApr 8, 2004Nationwide• ABX Diagnostics Inc

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Abbott Laboratories Diagnostic Div: Clinical Chemistry Uric Acid; LN 7D76-20

Unacceptable upward drift of results in control runs within 24 hour period.

FDAMar 18, 2004Nationwide• Abbott Laboratories Diagnostic Div

Roche Diagnostics Corp.: AMPLICOR HPV Microwell Plate Analyte Specific Reagent (MW...

Marketed without PMA or 510(k) approval.

FDAMar 10, 2004FL, VA• Roche Diagnostics Corp.

Roche Diagnostics Corp.: AMPLICOR HPV Master Mix Analyte Specific Reagent (HPV MMX...

Marketed without PMA or 510(k) approval.

FDAMar 10, 2004FL, VA• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Tecan clinical workstation; Tecan Genesis 150 front end, ...

If the files are not periodically purged from the TCW computer, it may result in patient identification/sample results mismatches.

FDAMar 5, 2004Nationwide• Roche Diagnostics Corp.

Diagnostic Products Corp: IMMULITE 2000 Intact PTH kit

High bias noted in samples collected with EDTA. Indication is to not run samples with EDTA.

FDAFeb 23, 2004CO, CT, MO +3 more• Diagnostic Products Corp

Genzyme Diagnostics: Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test k...

False Positive results.

FDAFeb 23, 2004MD, OH• Genzyme Diagnostics

Roche Diagnostics Corp.: Roche brand OMNI 4 Analyzer; catalog numbers GD0375 and G...

The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.

FDADec 29, 2003Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand OMNI 8 Analyzer; catalog numbers GD0455 and G...

The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.

FDADec 29, 2003Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand OMNI 1 Analyzer; catalog numbers GD0315 and G...

The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.

FDADec 29, 2003Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand OMNI 6 Analyzer; catalog numbers GD0415, GD04...

The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.

FDADec 29, 2003Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand OMNI 9 Analyzer; catalog numbers GD0475, GD04...

The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.

FDADec 29, 2003Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand OMNI 7 Analyzer; catalog numbers GD0435 and G...

The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.

FDADec 29, 2003Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand OMNI 5 Analyzer; catalog numbers GD0395 and G...

The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.

FDADec 29, 2003Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand OMNI 2 Analyzer; catalog numbers GD0335 and G...

The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.

FDADec 29, 2003Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand OMNI 3 Analyzer; catalog numbers GD0355, GD03...

The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.

FDADec 29, 2003Nationwide• Roche Diagnostics Corp.

Abbott Laboratories Diagnostic Div: Abbott Clinical Chemistry AEROSET c8000 Magnesium, List n...

Complaints that instructions for use were not clear.

FDADec 22, 2003Nationwide• Abbott Laboratories Diagnostic Div

Roche Diagnostics Corp.: Roche brand OMNI 8 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.