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Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc. Recalls

All product recalls associated with Roche Diagnostics Operations, Inc..

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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 4281–4300 of 4747 recalls

Roche Diagnostics Operations, Inc.: Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analy...

A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient.

FDAOct 7, 2009Nationwide• Roche Diagnostics Operations, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Vista System StreamLAB Analytical Workcell. Dim...

Incorrect result: An intermittent low result may be seen with the last test run from an aliquot on a Dimension Vista System when connected to a StreamLAB Analytical Workcell. The sample delivery sequence may deliver insufficient surplus volume to the low sensitivity aliquot (second aliquot). The surplus sample volume is occasionally insufficient to and can cause short sampling on the last test.

FDASep 1, 2009Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Vista System CHEM 1 CAL, Catalog Number KC110, ...

Siemens Healthcare Diagnostics, Inc. has confirmed high accuracy shifts with Dimension Vista URCA Flex reagent cartridge (various lots) when calibrating with some vials from CHEM 1 calibrator lot 9DM001.

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FDAAug 31, 2009Nationwide• Siemens Healthcare Diagnostics, Inc.

Window Blinds (Vertical Land) – Strangulation Risk (2009)

This recall involves all Vertical Land custom-made vertical and cellular window coverings that do not have a cord tensioning device and horizontal blinds that do not have inner cord stop devices. A sticker identification label can be found on the head rail of some of the window coverings which lists the company's name, address and telephone number.

CPSCAug 26, 2009Nationwide• Vertical Land Inc., of Panama City Beach, Fla.

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

Needles separate from the barrels of the syringes

FDAAug 21, 2009Nationwide• Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals: AccuSure, U-100, 31Gauge, 1/2cc Insulin Syringe, 5/16" (8...

Needles separate from the barrels of the syringes

FDAAug 21, 2009Nationwide• Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

Bay West & Hillyard Hybrid Wave N Cut Paper Towel Dispensers (Global Plastics) – fire hazard (2009)

Fire/Burn Risk

The recalled product is a Baywest & Hillyard Hybrid Wave N Cut hybrid paper towel dispenser. The product can operate in either a mechanical or electronic mode.

CPSCAug 5, 2009Nationwide• Global Plastics Ltd., of City of Industry, Calif.

Neuro Kinetics: VEST 6.6 or earlier software for use with Neuro Kinetics ...

Marketed without a 510k or PMA submission to include the normative data display.

FDAJul 24, 2009AL, AZ, CA +19 more• Neuro Kinetics

Sevylor Tow Behinds – connector break risk (2009)

The recall involves the following model Sevylor® Tow Behinds with Quick Hitch component. The Quick Hitches were manufactured between 2005 and 2009. Model No. Description 2000002098 Avenger ST2467 Daytona U362YEL Daytona U346RED Devil Ray ST9007 Double Threat U350BLK Double Threat U350GRN Double Threat ST2607 Drag'n Master U363RED Drag'n Master ST9401 Flight Blaster U338RED Flight Blaster ST2000 Le Biscuit U371RED Le Biscuit ST2540 Raging Racer U382PUR Raging Racer ST2650 Super Blaster U384BLU Super Blaster U384RED Super Blaster ST9300WM Triple Blaster ST9300 Triple Threat U351RED Triple Threat ST9050 Twin Blaster U349YEL Twin Blaster ST9075 Velocity Blaster U353YEL Velocity Blaster ST2467WM Wake Zone U362CMB Wake Zone

CPSCJul 23, 2009Nationwide• Shanghai Suofeng Plastic Metal Manufactures Co., Ltd., China

Roche Diagnostics Operations, inc.: Roche CoaguChek XS System, CoaguChek XS Professional Care...

The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.

FDAJul 22, 2009Nationwide• Roche Diagnostics Operations, inc.

Siemens Healthcare Diagnostics, Inc.: EasyLink Informatics System included with the Dimension V...

incorrect results may be transmitted to LIS

FDAJul 14, 2009Nationwide• Siemens Healthcare Diagnostics, Inc.

In-Wall Timers (Intermatic) – Shock Risk (2009)

This recall involves the Intermatic in-wall electronic timers with model numbers ST01, ST01C, ST01AC, ST01AC70, ST01C70, ST01CL, EI600C, EI600LAC, EI600LAC8, EI600WC, and EI600WC8. This product is a lamp and appliance timer and typically takes the place of a standard wall switch. The timer is white, off-white, or almond and measures 2 1/2 inches high by 1 3/4 inches wide. Model numbers can be found on the packaging and on the instruction. In-Wall timers are included in this recall if (1) the brand name "Intermatic" is molded on the front of the timer cover door, (2) the timer has only four keypad buttons, and (3) there is no 3-digit date code (e.g. "04C") stamped on the inside of the timer cover door. Timers with a 3-digit date code (e.g. "04C") stamped on the inside of the timer cover door are not included in this recall.

CPSCJul 1, 2009Nationwide• Intermatic Inc., of Spring Grove, Ill.

Siemens Healthcare Diagnostics, Inc.: Dimension Vista System BUN Flex Reagent Cartridge, Catalo...

Incorrect result: patient sample BUN results reported may be higher or lower than actual level.

FDAJun 16, 2009Nationwide• Siemens Healthcare Diagnostics, Inc.

Roche Diagnostics Corp.: Roche ACCU-CHEK Performa blood glucose test strips, Roche...

There may be a significant negative bias when testing neonate samples.

FDAJun 10, 2009Nationwide• Roche Diagnostics Corp.

Trek Diagnostic Systems: Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB ...

Thirty-one boxes of unapproved quarantine product, CP112-10 MHB w/LHB, Lot # 150444SA, were inadvertently shipped to customers on 6/2/09 instead of shipping approved Lot # 150344SA.

FDAJun 4, 2009Nationwide• Trek Diagnostic Systems

Single Cup Pod Brewers (Bunn) – Burn Hazard (2009)

Fire/Burn Risk

This recall involves Bunn® Single Pod Brewers. Models included in the recall are MCP (My Café Pourover) and MCA (My Café Automatic). The pod brewers have a black body with stainless backsplash and measure 12 inches high by 8 inches wide. "Bunn®" is printed on the front and lights up when the pod brewer is on.

CPSCMay 21, 2009Nationwide• Bunn-O-Matic Corp., of Springfield, Ill.

Siemens Healthcare Diagnostics Inc.: IMMULITE 2000/2500 Chemiluminescent Substrate Module For...

These substrate lots have shown a tendency to introduce a shift in both control and patient results with multiple methods.

FDAMay 15, 2009Nationwide• Siemens Healthcare Diagnostics Inc.

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 Compact Plus Meter Kit, Roche Diagnostics...

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

FDAMay 13, 2009Nationwide• Roche Diagnostics Corp.