The Recall Desk

Hazard

Inaccurate Reading recalls

100 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
100
Critical
2
Severe
2
Most recent
2021-05-26

Of the 100 inaccurate reading recalls we have scored against our rubric, 2 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (2%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all inaccurate reading recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

76–100 of 100

  • CriticalFDA (Devices)·Z-1212-2014·2014-03-26

    Abbott Recalls FreeStyle Flash Blood Glucose Meters Due to Inaccurate Results

    Abbott Diabetes Care is recalling FreeStyle Flash Blood Glucose Monitors because they may produce inaccurate low blood glucose readings when used with specific test strips.

    Product
    FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions wi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1211-2014·2014-03-26

    Abbott FreeStyle Blood Glucose Monitors Recalled for Inaccurate Results

    Abbott Diabetes Care is recalling FreeStyle Blood Glucose Monitors because they may produce inaccurate blood glucose readings when used with specific test strips.

    Product
    FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C). Use test strips only within the system operating temperature range as outlined in your Owner's Booklet. Meter made in China; Distributed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1178-2014·2014-03-19

    Lin-Zhi International Recalls Cannabinoid DAU Calibrator Controls

    Lin-Zhi International is recalling specific lots of Cannabinoid DAU Calibrator Controls because they may provide inaccurate concentration readings near expiration.

    Product
    Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liqu
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1179-2014·2014-03-19

    Lin-Zhi International Recalls Cannabinoid DAU Calibrator Controls Due to Concentration Drift

    Lin-Zhi International is recalling specific lots of Cannabinoid DAU Calibrator Controls because they may provide inaccurate concentration readings near expiration.

    Product
    Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liqu
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0486-2014·2013-12-25

    Abbott FreeStyle Blood Glucose Test Strips Recalled for Erroneous Low Results

    Abbott Diabetes Care is recalling certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips because they may produce erroneously low blood glucose readings.

    Product
    FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count Product of Ireland; UPC 6 99073 70819 9; - 50 count UPC 6 99073 70822 9 - 50 count UPC 6 99073 71026 0 - 50 count UPC 6 99073 70827 4 - 100 count Manufactured by Abbott Dia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0386-2014·2013-12-04

    Lin-Zhi International Recalls Norbuprenorphine Urine Control Material

    Lin-Zhi International is recalling Norbuprenorphine Level 2 Controls because the analyte degrades, causing decreased concentration readings.

    Product
    Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International, I
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1901-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical is recalling Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings.

    Product
    Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into Nova Max Glucose Test Strip System Kits 43435 and 45507 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1898-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical is recalling Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings.

    Product
    Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1903-2013·2013-08-21

    Nova Max Plus Glucose Monitor Kits Recalled for False High Readings

    Nova Biomedical is recalling Nova Max Plus Monitor Systems because test strips may produce false abnormally high glucose readings.

    Product
    Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intende
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1906-2013·2013-08-21

    Nova Max Plus Monitor System Recalled for False High Glucose Readings

    Nova Biomedical is recalling Nova Max Plus Monitor Systems because test strips may produce false abnormally high glucose readings.

    Product
    Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monito
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1905-2013·2013-08-21

    Nova Max Plus Monitor System Recalled for False High Glucose Readings

    Nova Biomedical is recalling Nova Max Plus Monitor Systems because the test strips may produce false abnormally high glucose readings.

    Product
    Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1904-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical is recalling Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings, potentially affecting diabetes management.

    Product
    Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1733-2013·2013-07-24

    Terumo Recalls CDI 500 Blood Parameter Monitoring System Due to Software Error

    Terumo is recalling 3,972 CDI 500 Blood Parameter Monitoring Systems because a software algorithm inaccuracy was discovered during internal testing.

    Product
    CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1731-2013·2013-07-24

    Terumo Recalls CDI 500 Blood Parameter Monitoring System Due to Software Error

    Terumo is recalling the CDI 500 Blood Parameter Monitoring System because software inaccuracies were found in the algorithm. A software update is being developed to correct the issue.

    Product
    CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, he
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1732-2013·2013-07-24

    Terumo Recalls CDI 500 Blood Parameter Monitoring Systems

    Terumo is recalling CDI 500 Blood Parameter Monitoring Systems because software contains unused accuracy correction factors for hematocrit and saturation calculations.

    Product
    CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperatur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1403-2013·2013-06-05

    PTS Glucose Test Strips Recalled for Under-Recovery of Glucose

    Polymer Technology Systems is recalling PTS Glucose Test Strips because internal testing showed under-recovery of glucose, which could lead to inaccurate readings.

    Product
    PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1245-2013·2013-05-15

    Abbott FreeStyle InsuLinx Blood Glucose Meter Recall for Inaccurate Readings

    Abbott is recalling FreeStyle InsuLinx meters because they may provide inaccurate readings at rare, extremely high glucose levels (1024 mg/dL and above).

    Product
    FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1154-2013·2013-05-01

    Nova StatStrip Xpress Glu-Test Strips Recalled for No Result Messages

    Nova Biomedical Corporation is recalling specific lots of Nova StatStrip Xpress Glu-Test Strips because they may display a 'no result' message when tested.

    Product
    Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1153-2013·2013-05-01

    Nova StatStrip Xpress Glu-Test Strips Recalled for No Result Messages

    Nova Biomedical is recalling specific lots of Nova StatStrip Xpress Glu-Test Strips because they may display a 'no result' message when tested.

    Product
    Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1074-2013·2013-04-24

    Lifescan Recalls OneTouch Verio IQ Blood Glucose Meters for Display Error

    Lifescan is recalling OneTouch Verio IQ Blood Glucose Meters because they shut off instead of displaying 'EXTREME HIGH GLUCOSE' at high readings.

    Product
    All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio IQ Warranty Meter. Product Usage: The OneTouch¿ VerioIQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of gluc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1129-2013·2013-04-24

    LifeScan OneTouch Ultra Control Solution Recalled for Potential Meter Readings

    LifeScan Inc is recalling OneTouch Ultra Control Solution because it may cause blood glucose meters to display results outside the expected range, even when the system is working properly.

    Product
    LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1130-2013·2013-04-24

    LifeScan OneTouch Select Control Solution Recalled for Potential Meter Readings

    Lifescan Inc is recalling OneTouch Select Control Solution because it may cause blood glucose meters to display results outside the expected range, even when the system is working properly.

    Product
    LifeScan brand OneTouch¿ Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1029-2013·2013-04-10

    Philips Ingenuity TF PET/CT Software Update Addresses Potential Safety Risks

    Philips is updating software on one Ingenuity TF PET/CT system in Ohio to fix issues that could cause inaccurate readings or pose risks to patients and staff.

    Product
    Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1862-2012·2012-07-04

    Stryker MA204 Bed Recall Due to Loadcell Failure in Scale Function

    Stryker is recalling MA204 beds because loadcells in the scale and bed exit systems are failing at an abnormally high rate.

    Product
    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·10092·2009-12-23

    Cressi Scuba Regulators Recalled Due to Drowning Risk

    Cressi is recalling Ellipse Black MC5 scuba regulators because inaccurate pressure gauge readings pose a drowning hazard to divers.

    Product
    Cressi Ellipse Black MC5 Regulator
    Category
    Consumer Product
    Distribution
    Distributed nationwide