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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

579

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 3581–3600 of 10937 recalls

Randox Mg R1 Test (Randox) – Linearity Performance (2020)

Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine

Low

FDANov 13, 2020Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Randox Rx Series Mg Test (Randox) – Linearity Performance (2020)

Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine

Moderate

FDANov 13, 2020Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Petite Diced Tomatoes (Sysco Arrezzio) – foreign material (2020)

Recall due to presence of foreign material. Foreign object is made out of black and hard plastic.

Class II

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Moderate

FDANov 13, 2020AZ, IN, UT• The Neil Jones Food Company

Intellis Spinal Cord Stimulator (Medtronic) – Programming Issue (2020)

A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.

Moderate

FDANov 12, 2020Nationwide• Medtronic Neuromodulation

Stimulan Kit (Biocomposites) – Mislabeling (2020)

The product is mislabeled.

Low

FDANov 12, 2020Nationwide• Biocomposites, Ltd. Keele Science Park Keele Staffordshire United Kingdom

RayStation Software (RaySearch) – Treatment Report Issue (2020)

Two issues were found with the treatment plan report: 1) There may be incorrect information for the percent of a region of interest with a clinical goal that is outside the dose grid; and 2) For RayStation and RayPlan 9B and 10A, 6D couch angles may be incorrect.

Moderate

FDANov 11, 2020Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

Canon PET-CT Scanner (Canon) – Scan Progression (2020)

A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the diagnostic imaging system failing resulting in rescanning and reinjection of contrast medium.

Moderate

FDANov 11, 2020Nationwide• Canon Medical System, USA, INC.

ELI 380 Electrocardiograph (Welch Allyn) – Wireless Disconnect (2020)

The radio within the device can become disassociated with the wireless access point.

Moderate

FDANov 11, 2020Nationwide• WELCH ALLYN, INC/MORTARA

Levocetirizine Tablets (InvaTech) – Stability Failure (2020)

Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.

Class IIILow

FDANov 11, 2020Nationwide• InvaTech Pharma Solutions, LLC

Capiox FX25 Oxygenator (Terumo) – Configuration Error (2020)

Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)

Moderate

FDANov 11, 2020Nationwide• Terumo Cardiovascular Systems Corporation

Embolization Kit (Merit Medical) – Sterile Barrier (2020)

Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical treatment.

High

FDANov 10, 2020KY, MD, RI• Merit Medical Systems, Inc.

Cardiac Cath Pack (Merit Medical) – Sterile Barrier (2020)

High

FDANov 10, 2020KY, MD, RI• Merit Medical Systems, Inc.

Custom Inflation Kit (Merit Medical) – Sterile Barrier (2020)

High

FDANov 10, 2020KY, MD, RI• Merit Medical Systems, Inc.

Shimadzu Mobile X-Ray (Shimadzu) – Handle Bolts (2020)

There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device.

High

FDANov 9, 2020Nationwide• Shimadzu Medical Systems

Cogent Monitoring System (ICU Medical) – Cardiac Output (2020)

Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.

Moderate

FDANov 9, 2020Nationwide• ICU Medical, Inc.

Canon Aquilion Prime CT (Canon) – Scan Progression (2020)

A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan failing resulting in rescanning and reinjection of contrast medium.

Moderate

FDANov 9, 2020Nationwide• Canon Medical System, USA, INC.

Sentinel Monitor (Spacelabs) – Test Comment Issue (2020)

During system upgrade incorrect comments may be added to existing tests. In such instance: Resting ECG and ABP tests which did not contain comments at the time of the upgrade, may have unrelated comments added. Existing comments will not be overwritten or removed. Rhythm ECG Tests may have comments overwritten with unrelated comments. Any tests created after the upgrade are not affected.

Moderate

FDANov 6, 2020Nationwide• Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom