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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

1000

Past Year

304

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 4301–4320 of 4747 recalls

Roche Diagnostics Corp.: Roche ACCU-CHEK Softclix Lancing Device, Distributed by R...

The lancet cap may be missing, which could result in an unintended lancet stick to the user.

FDAMay 13, 2009Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche ACCU-Chek Voicemate Meter, Roche Diagnostics, India...

The lancet cap may be missing, which could result in an unintended lancet stick to the user.

FDAMay 13, 2009Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche ACCU-Chek Active Meter Kit, Roche Diagnostics, Indi...

The lancet cap may be missing, which could result in an unintended lancet stick to the user.

FDAMay 13, 2009Nationwide

1...214 215216217 218...238

Page 216 of 238Next

• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche/Hitachi Preciset TDM I, Roche Diagnostics, Indianap...

The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the application of the force required to open the bottles.

FDAApr 22, 2009Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indiana...

The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the application of the force required to open the bottles.

FDAApr 22, 2009Nationwide• Roche Diagnostics Corp.

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals: AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm...

Needles separate from the barrel of the syringes.

FDAApr 9, 2009Nationwide• Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

Roche Diagnostics Corp.: Roche cobas 6000 analyzer series (including cobas c 501 a...

Some data alarm flags do not transfer from the analyzer to the laboratory information system, since not all data flags are recognized by the instrument manager/middleware.

FDAApr 1, 2009Nationwide• Roche Diagnostics Corp.

Spectranetics Corporation: Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, ...

Catheter outer jacket may split during use.

FDAMar 16, 2009Nationwide• Spectranetics Corporation

Neuronetics, Inc.: NeuroStar TMS Therapy System/SenStar Treatment Link. The...

Fire/Burn Risk

SenStar Treatment Link may have an open circuit that during use with the NeuroStar TMS Therapy system may cause arcing and heat damage to the SenStar and/or treatment coil. Heating of the SenStar during use has a potential risk of minor scalp burn to patients.

FDAMar 16, 2009Nationwide• Neuronetics, Inc.

Diagnostic Chemicals, Ltd.: DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagen...

Labeled with extended expiration date (24 months instead of 18 months)

FDAFeb 12, 2009Nationwide• Diagnostic Chemicals, Ltd.

Roche Diagnostics Corp.: Roche MagNA Pure LC Workstation; Product Numbers: 1223693...

Laceration Risk

Protruding screw threads may cut the user when cleaning the interior of the instrument.

FDAFeb 9, 2009Nationwide• Roche Diagnostics Corp.

Cyberkinetics Neurotechnology Systems, Inc.: Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expira...

Sterility of product cannot be assured

FDAFeb 4, 2009Nationwide• Cyberkinetics Neurotechnology Systems, Inc.

Volk Optical Inc: Optiflex Lens Positioning Unit (LPU) Product Code: 10970...

Lens may fall onto eye surface during procedure. Ophthalmologic device had a loose set screw on the Ball-Seal bushing assembly. As a result, the set screw becomes disengaged from the set screw groove in the bushing assembly and the Lens Positioning Unit slides downward.

FDAJan 23, 2009IN, MO• Volk Optical Inc

Diagnostic Hybrids Inc: Rabbit Kidney Culture, brand name: 'FreshCells'. The pr...

During QC post release monitoring, the firm determined that the monolayer culture of rabbit kidney cells previously distributed by the firm, appeared to contain another type of cells (monkey kidney cells).

FDAJan 21, 2009Nationwide• Diagnostic Hybrids Inc

Siemens Medical Solutions Diagnostics: Immulite 2000 and Immulite 2500 digital Fluidics PC Board...

Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper.

FDAJan 5, 2009AZ, CA, FL +12 more• Siemens Medical Solutions Diagnostics

Philips Healthcare Informatics, Inc.: iSite PACS (Picture Archiving and Communications System) ...

Product may display clinical reports with the study date and time in GMT format, which may not be obvious to the end user, who may expect to see the local time in the report.

FDADec 29, 2008Nationwide• Philips Healthcare Informatics, Inc.

Mountain Cat Snowmobiles (Arctic Cat) – Fire Hazard (2008)

Fire/Burn Risk

This recall involves all 2009 model Mountain Cat and Crossfire snowmobiles within the Vin number range of 103896 through 118441. The Vin number can be found stamped into the tunnel near the right-side footrest.

CPSCDec 16, 2008Nationwide• Arctic Cat Inc., of Thief River Falls, Minn.

Roche Diagnostics Corp.: Roche COBAS c 111 Analyzer with ISE module option, GMMI N...

Due to a manufacturing error at the supplier, not all cobas c 111 pinch valve caps are properly glued to the correct position on the pinch valve shaft. Without the glue, the cap can become loose or misaligned. The effect of these faulty valves is that they may not open or close properly which can disturb the fluid transportation within the ISE module resulting in problems with ISE calibration, con

FDANov 17, 2008Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche/Hitachi Modular Analytics System, clinical chemistr...

If a masked module is unmasked during the reagent registration process, the calibration parameters may be assigned to the wrong reagents, resulting in the reporting of incorrect control and sample results.

FDANov 12, 2008Nationwide• Roche Diagnostics Corp.

Micro Therapeutics Inc, dba ev3 Neurovascular: Axium Detachable Coil System Model Number: QC-2-2-3D. Th...

ev3 Neurovascular has identified an incorrect expiration date on the label of one lot of ev3 Axium coils Catalog QC-2-2-3D. This lot 5871057 shows an expiration date of 0211-04. The expiration date should read 2011-04. There are no functional issues with the coils in question as the appropriate expiration date is 2011.

FDANov 12, 2008Nationwide• Micro Therapeutics Inc, dba ev3 Neurovascular