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Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland Recalls

All product recalls associated with Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland.

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Recall Summary

Total Recalls

1000

Past Year

581

Class I (Serious)

Most Recent

Dec 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 2021–2040 of 10937 recalls

Specific Protein Control (Randox) – Rheumatoid Factor Decrease (2022)

Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range

Moderate

FDANov 22, 2022Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Guardian Glucose Monitoring App (Medtronic) – Logout Issue (2022)

An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logged out, linked care partners will not receive SMS notifications (could result in hypoglycemia or hyperglycemia), and sensor glucose values will also not be sent to the InPen app.

Moderate

FDANov 21, 2022Nationwide• Medtronic MiniMed

Proveo 8 Microscope (Leica) – Power Supply Overheat (2022)

There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

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High

FDANov 21, 2022Nationwide• Leica Microsystems, Inc.

Provido Microscope (Leica) – Power Supply Overheat (2022)

High

FDANov 21, 2022Nationwide• Leica Microsystems, Inc.

M530 OHX Microscope (Leica) – Power Supply Overheat (2022)

High

FDANov 21, 2022Nationwide• Leica Microsystems, Inc.

Ventana PD-L1 Assay (Ventana) – Light Staining Issue (2022)

Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent positivity, which could potentially lead to a false-negative PD-L1 result.

Moderate

FDANov 18, 2022Nationwide• Ventana Medical Systems, Inc.

MATRYX, AXYS, Pro-Ride Snowmobiles (Polaris) – Fire Hazard (2022)

Fire/Burn Risk

This recall involves Polaris Model Years 2021 through 2023 MATRYX, model years 2015 through 2022 AXYS, and certain 2013 and 2014 Pro-Ride snowmobiles. The recalled snowmobiles were sold in black and in custom color combinations. Polaris and the model names are printed on the chassis on both sides of the snowmobiles. The model year and VIN are stamped on the right side of the tunnel. Consumers can enter their VIN at www.polaris.com/en-us/off-road-recalls/ to see if their snowmobile is included in any recalls.

High

CPSCNov 17, 2022Nationwide• Polaris Industries Inc., of Medina, Minnesota

B125M Patient Monitor (GE Medical) – CO2 Measurement Error (2022)

GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.

Moderate

FDANov 16, 2022Nationwide• GE Medical Systems, LLC

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Moderate

FDANov 10, 2022Nationwide• GE Medical Systems, LLC

Vivid S5 Ultrasound (GE Medical) – Battery Failure (2022)

Fire/Burn Risk

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Moderate

FDANov 10, 2022Nationwide• GE Medical Systems, LLC

Vivid q N Ultrasound (GE Medical) – Battery Failure (2022)

Fire/Burn Risk

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Moderate

FDANov 10, 2022Nationwide• GE Medical Systems, LLC

Vivid S5 N Ultrasound (GE Medical) – Battery Failure (2022)

Fire/Burn Risk

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Moderate

FDANov 10, 2022Nationwide• GE Medical Systems, LLC

Vivid S6 Ultrasound (GE Medical) – Battery Failure (2022)

Fire/Burn Risk

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Moderate

FDANov 10, 2022Nationwide• GE Medical Systems, LLC

Vivid i N Ultrasound (GE Medical) – Battery Failure (2022)

Fire/Burn Risk

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Moderate

FDANov 10, 2022Nationwide• GE Medical Systems, LLC

PF-Neostigmine Injection (Nephron) – Cross Contamination Risk (2022)

CGMP Deviations: Potential for cross contamination due to product carry over.

Class IIModerate

FDANov 10, 2022Nationwide• Nephron Sterile Compounding Center LLC

PF-Labetalol HCl Injection (Nephron) – Cross Contamination Risk (2022)

CGMP Deviations: Potential for cross contamination due to product carry over.

Class IIModerate

FDANov 10, 2022Nationwide• Nephron Sterile Compounding Center LLC

Vivid i Ultrasound (GE Medical) – Battery Failure (2022)

Fire/Burn Risk

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Moderate

FDANov 10, 2022Nationwide• GE Medical Systems, LLC

Stay Informed

Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland Recalls

Recall Summary

Specific Protein Control (Randox) – Rheumatoid Factor Decrease (2022)

Guardian Glucose Monitoring App (Medtronic) – Logout Issue (2022)

Proveo 8 Microscope (Leica) – Power Supply Overheat (2022)

Provido Microscope (Leica) – Power Supply Overheat (2022)

M530 OHX Microscope (Leica) – Power Supply Overheat (2022)

Ventana PD-L1 Assay (Ventana) – Light Staining Issue (2022)

MATRYX, AXYS, Pro-Ride Snowmobiles (Polaris) – Fire Hazard (2022)

B125M Patient Monitor (GE Medical) – CO2 Measurement Error (2022)

B105P Patient Monitor (GE Medical) – CO2 Measurement Error (2022)

B125P Patient Monitor (GE Medical) – CO2 Measurement Error (2022)

B105M Patient Monitor (GE Medical) – CO2 Measurement Error (2022)

Vivid q Ultrasound (GE Medical) – Battery Failure (2022)

Vivid S5 Ultrasound (GE Medical) – Battery Failure (2022)

Vivid q N Ultrasound (GE Medical) – Battery Failure (2022)

Vivid S5 N Ultrasound (GE Medical) – Battery Failure (2022)

Vivid S6 Ultrasound (GE Medical) – Battery Failure (2022)

Vivid i N Ultrasound (GE Medical) – Battery Failure (2022)

PF-Neostigmine Injection (Nephron) – Cross Contamination Risk (2022)

PF-Labetalol HCl Injection (Nephron) – Cross Contamination Risk (2022)

Vivid i Ultrasound (GE Medical) – Battery Failure (2022)