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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

100

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 321–340 of 2670 recalls

Liquid Assayed Chemistry Control (Randox) – instructions error (2023)

there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.

Moderate

FDAAug 3, 2023GA, OH, OR +3 more• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Helix CBD Clinical Cream (Parker Labs) – CGMP Manufacturing Issues (2023)

CGMP Deviations

Class IIModerate

FDAAug 2, 2023Nationwide• Parker Laboratories, Inc.

Helix Pain Relief Cream (Parker Labs) – CGMP Manufacturing Issues (2023)

CGMP Deviations

1...15 161718 19...134

Page 17 of 134Next

Class II

Moderate

FDAAug 2, 2023Nationwide• Parker Laboratories, Inc.

Protex Hand Sanitizer (Parker Labs) – CGMP Manufacturing Issues (2023)

CGMP Deviations

Class IIModerate

FDAAug 2, 2023Nationwide• Parker Laboratories, Inc.

Helix Tri-Active Therapy Cream (Parker Labs) – CGMP Manufacturing Issues (2023)

CGMP Deviations

Class IIModerate

FDAAug 2, 2023Nationwide• Parker Laboratories, Inc.

Helix CBD Therapy Cream (Parker Labs) – CGMP Manufacturing Issues (2023)

CGMP Deviations

Class IIModerate

FDAAug 2, 2023Nationwide• Parker Laboratories, Inc.

Randox Liquid Protein Calibrator (Randox) – Ferritin Restandardization (2023)

As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into batches 627222, 627224, 634886 and 634887 have been reassigned as part of the restandardization. Following this restandardization, Ferritin results for Quality Control material and patient samples recovered erroneously higher than the targeted calibrator values by approximately +10% across the assay range following.

Moderate

FDAJul 19, 2023CA, FL, IL +6 more• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Fosfomycin Tromethamine Granules (Ascend) – Impurity Specification Failure (2023)

Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.

Class IIILow

FDAJul 18, 2023Nationwide• Ascend Laboratories, LLC

RayCare Software (RaySearch) – Allergy Warning Issue (2023)

An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances

High

FDAJul 17, 2023Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

Yamaha Personal Transportation Vehicles – Crash Injury Hazard (2023)

This recall involves Yamaha Personal Transportation Vehicles. The vehicles were sold in various colors including white, blue, green and orange. The model's name is found on the left and right side of the vehicle and the serial number can be found on the frame under the operator's seat. 2023 J0D Drive2 QuieTech PTV J0D 600665 602162 J0E Drive2 Powertech AC PTV J0E 600109 600468 J0P UMAX Rally 2+2 AC J0P 705 739 J2D Concierge 4E J2D 100101 100421 J5C Drive2 Powertech AC Li PTV J5C 400104 400139

High

CPSCJul 13, 2023Nationwide• Yamaha Motor Powered Products Co. Ltd., of Japan

ACL TOP Family Analyzer (Instrumentation Lab) – Result Misidentification (2023)

Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result

High

FDAJul 13, 2023Nationwide• Instrumentation Laboratory

Fingolimod Capsules (Ascend) – dissolution failure (2023)

Failed Dissolution Specifications

Class IIModerate

FDAJul 11, 2023Nationwide• Ascend Laboratories, LLC

Big J Unbleached Flour (Big J Mill) – Potential filth (2023)

Flour may have filth.

Class IIILow

FDAJul 11, 2023IN, UT• Big J Mill & Elevator Company, Incorporated

Golden Loaf Bakers Flour (Big J Mill) – Potential filth (2023)

Flour may have filth.

Class IIILow

FDAJul 11, 2023IN, UT• Big J Mill & Elevator Company, Incorporated

Five S 5 3x65, REF: 0915612-06, sterile for single use, S... (Karl Storz Endoscopy) – flexible intubation endoscopes steri... (2023)

Flexible intubation endoscopes sterility assurance can not be confirmed.

High

FDAJul 7, 2023Nationwide• Karl Storz Endoscopy

Golf Cars and PTVs (Yamaha) - vehicle safety issue (2023)

This recall involves model year 2023 Golf Car and Personal Transportation vehicles. The vehicles were sold in various colors including white, blue, green and orange. The model name is located on the left and right side of the vehicle and the serial number can be found on the frame under the operator's seat.

High

CPSCJul 6, 2023Nationwide• Yamaha Motor Powered Products Co. LTD., of Japan

2023 THOR MOTOR COACH TRANQUILITY – thor motor coach (tmc) is recalling c... (2023)

Thor Motor Coach (TMC) is recalling certain 2022-2024 Tranquility and 2022-2023 Sanctuary motorhomes. The R-bike rack arms may fracture and detach.

High

NHTSAJun 27, 2023Nationwide• THOR MOTOR COACH

Safe Tussin DM Cough Syrup (Kramer) – Non-Food Grade Lubricant (2023)

CGMP Deviations: use of non-food grade lubricant in mixing vessel.

Class IIModerate

FDAJun 23, 2023Nationwide• Kramer Laboratories, Inc.

Safe Tussin PM Cough Syrup (Kramer) – Non-Food Grade Lubricant (2023)

CGMP Deviations: use of non-food grade lubricant in mixing vessel.

Class IIModerate

FDAJun 23, 2023Nationwide• Kramer Laboratories, Inc.

Liquid Urine Control (Randox) – Test Result Variation (2023)

(1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for cortisol. (3) There has been a transcription error for Creatinine in the Instructions For Use (IFU). The target and ranges for Creatinine for the Roche Creatinine Plus method have been listed incorrectly. These failures cause a delay in patient results for the above mentioned analytes.

Moderate

FDAJun 21, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland