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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

583

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 1261–1280 of 10937 recalls

Calibration Serum Level 3 (Randox) – Alkaline Phosphatase Misassignment (2023)

Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples

FDANov 20, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Whole Cantaloupe 1/3 CT (FreshPoint) – Salmonella Risk (2023)

Salmonella

Potential Salmonella contamination.

Class IHigh

FDANov 17, 2023IA, MN, ND +1 more• FreshPoint Bix Produce Company, LLC

Bix Produce Mixed Fruit with Grapes (FreshPoint) – Salmonella Risk (2023)

Salmonella

Potential Salmonella contamination.

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Class IHigh

FDANov 17, 2023IA, MN, ND +1 more• FreshPoint Bix Produce Company, LLC

Mixed Fruit Cup (FreshPoint) – Salmonella Risk (2023)

Salmonella

Potential Salmonella contamination.

Class IHigh

FDANov 17, 2023IA, MN, ND +1 more• FreshPoint Bix Produce Company, LLC

Bix Produce Mixed Fruit (FreshPoint) – Salmonella Risk (2023)

Salmonella

Potential Salmonella contamination.

Class IHigh

FDANov 17, 2023IA, MN, ND +1 more• FreshPoint Bix Produce Company, LLC

Bix Produce Fruit Mix (FreshPoint) – Salmonella Contamination (2023)

Salmonella

Potential Salmonella contamination.

Class IHigh

FDANov 17, 2023IA, MN, ND +1 more• FreshPoint Bix Produce Company, LLC

Bix Produce Cut Cantaloupe (FreshPoint) – Salmonella Risk (2023)

Salmonella

Potential Salmonella contamination.

Class IHigh

FDANov 17, 2023IA, MN, ND +1 more• FreshPoint Bix Produce Company, LLC

Cantaloupe Fruit Cup (FreshPoint) - Salmonella Risk (2023)

Salmonella

Potential Salmonella contamination.

Class IHigh

FDANov 17, 2023IA, MN, ND +1 more• FreshPoint Bix Produce Company, LLC

Chunk Melon with Grape (FreshPoint) - Salmonella Risk (2023)

Salmonella

Potential Salmonella contamination.

Class IHigh

FDANov 17, 2023IA, MN, ND +1 more• FreshPoint Bix Produce Company, LLC

PosiFlush Saline Syringe (BD) – Incorrect Stopper (2023)

An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General Pump Compatibility. The use of BD PosiFlush Prefilled Flush Syringes with this stopper causes an increase in injection force, which has the potential to trigger alarms if used with a syringe pump.

FDANov 16, 2023Nationwide• Becton Dickinson & Company

X-ray System (Canon) – Detector Image Abnormality (2023)

VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.

FDANov 15, 2023CA, LA• Canon Medical System, USA, INC.

Guardian 4 Glucose Sensor (Medtronic) – GOX Layer Thickness (2023)

Laceration Risk

Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 m). A non-conforming GOX layer thickness could impact sensor function (sensor glucose value) or loss of sensor function due to the sensor layer being too thin. The potential impact resulting from this issue ranges from user inconvenience to over/under delivery of insulin, possibly resulting in hyperglycemia or hypoglycemia, if the sensor glucose values are affected. The issue was identified by the manufacturing team during the execution of Filmetrics Measurement for a Guardian Sensor lot.

FDANov 15, 2023Nationwide• Medtronic MiniMed, Inc.