The Recall Desk

Manufacturer

Roche Diagnostics Operations, Inc.

127 recalls in our database name Roche Diagnostics Operations, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
127
Critical
0
Severe
19
Most recent
2026-03-11

Of the 127 recalls from Roche Diagnostics Operations, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 19 (15%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–100 of 127

  • ModerateFDA (Devices)·Z-2330-2015·2015-08-12

    Roche Cobas b 221 S2 Fluid Pack Recall for Transponder Error

    Roche is recalling S2 Fluid Packs for the Cobas b 221 system because they may generate a transponder error, preventing the instrument from starting measurements.

    Product
    S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes Analyzer; The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calci
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1923-2015·2015-07-08

    Roche Creatinine Plus Reagent Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Creatinine Plus reagent because it may produce falsely decreased results when used with certain drugs.

    Product
    Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1922-2015·2015-07-08

    Roche Creatinine Plus Reagent Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Creatinine Plus reagents because acetaminophen and N-acetylcysteine may cause falsely decreased test results.

    Product
    Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1924-2015·2015-07-08

    Roche HDL-Cholesterol gen.3. Recalled for Potential Drug Interference

    Roche Diagnostics is recalling HDL-Cholesterol gen.3. reagents due to potential false results caused by drug interference on Cobas Analyzers.

    Product
    HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1929-2015·2015-07-08

    Roche Triglycerides GPO Test Recalled for Potential Drug Interference

    Roche is recalling Triglycerides GPO tests because certain drugs may cause falsely decreased results on specific Cobas analyzers.

    Product
    Triglycerides GPO. In vitro test for the quantitative determination of triglycerides in human serum and plasma on the COBAS Integra 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1928-2015·2015-07-08

    Roche LDL-Cholesterol Test Recalled for Potential Drug Interference

    Roche Diagnostics is recalling 6,255 units of the LDL-Cholesterol plus gen.2. test due to potential false results caused by drug interference.

    Product
    LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1927-2015·2015-07-08

    Roche LDL-Cholesterol Test Recalled for Potential Drug Interference

    Roche Diagnostics is recalling the LDL-Cholesterol gen.2 test because certain drugs may cause falsely decreased results when using the Trinder reaction method.

    Product
    LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1930-2015·2015-07-08

    Roche Diagnostics Recalls Triglycerides/Glycerol Blanked In Vitro Test Kits

    Roche Diagnostics is recalling 6,255 units of Triglycerides/Glycerol Blanked in vitro test kits due to possible drug interference that may cause falsely decreased results.

    Product
    Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODULAR systems, and cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1921-2015·2015-07-08

    Roche Cholesterol Gen.2 Cassette Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Cholesterol Gen.2 cassettes because Trinder reaction tests may yield falsely decreased results when specific drugs are present.

    Product
    Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of total cholesterol in serum a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1931-2015·2015-07-08

    Roche Uric Acid Plus Test Recalled for Drug Interference

    Roche Diagnostics is recalling Uric Acid plus ver.2 tests because results may be falsely decreased when used with certain drugs.

    Product
    Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULAR systems, cobas c111, COBAS Integra 800 and 400 plus systems, and cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1925-2015·2015-07-08

    Roche HDL-Cholesterol Reagent Recalled for Potential Drug Interference

    Roche Diagnostics is recalling HDL-Cholesterol plus gen.3. reagents due to potential false results when used with certain drugs.

    Product
    HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1926-2015·2015-07-08

    Roche Lactate Reagent Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Lactate reagent due to potential false results caused by drug interference with the Trinder reaction method.

    Product
    Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plasm and cerebrospinal fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1920-2015·2015-07-08

    Roche Cholesterol Reagent Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Cholesterol CHOD-PAP reagents because drug interference may cause falsely decreased test results.

    Product
    Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1622-2015·2015-05-27

    Roche Homocysteine Test System Recalled for Inaccurate Low Results

    Roche Diagnostics is recalling Homocysteine Reagent lots due to complaints of under-recovery and falsely low patient results, which could delay diagnosis of peripheral vascular disease.

    Product
    Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1041-2015·2015-02-11

    Roche Cobas b 221 Blood Gas Analyzer Recalled for Measurement Bias

    Roche Diagnostics is recalling 103 Cobas b 221 analyzers because bacterial contamination causes inaccurate glucose and lactate readings.

    Product
    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0889-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender II Infusion Sets Due to Tubing Detachment

    Roche Diagnostics is recalling ACCU-CHEK Tender II infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender II 13/60 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0885-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk

    Roche Diabetes Care is recalling ACCU-CHEK Tender I infusion sets because tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender I 13/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0894-2015·2015-01-07

    ACCU-CHEK Tender II Infusion Sets Recalled for Tubing Detachment Risk

    Roche Diagnostics is recalling ACCU-CHEK Tender II infusion sets because tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender II 17/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0888-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk

    Roche Diagnostics is recalling ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0883-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk

    Roche Diagnostics is recalling ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK¿ Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2015·2015-01-07

    ACCU-CHEK Tender II Infusion Sets Recalled for Tubing Detachment Risk

    Roche Diagnostics is recalling ACCU-CHEK Tender II infusion sets because tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0892-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender II Infusion Sets Due to Tubing Detachment

    Roche is recalling ACCU-CHEK Tender II infusion sets because tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender II 17/60 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0891-2015·2015-01-07

    ACCU-CHEK Tender II Infusion Sets Recalled for Tubing Detachment Risk

    Roche Diagnostics is recalling ACCU-CHEK Tender II infusion sets because tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0886-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk

    Roche Diagnostics is recalling 13,041 boxes of ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0893-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender II Infusion Sets Due to Tubing Detachment

    Roche is recalling ACCU-CHEK Tender II infusion sets because tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections th
    Category
    Medical Device
    Distribution
    Distributed nationwide