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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

567

Class I (Serious)

Most Recent

Jan 2026

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 981–1000 of 7756 recalls

Microalbumin Calibrator (Randox) – Result Misclassification (2024)

Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.

FDAJan 31, 2024Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

CVS Health Eye Ointment (Brassica) – Sterility Concern (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 30, 2024Nationwide• Brassica Pharma Pvt Ltd

Equate Stye Eye Ointment (Brassica) – Sterility Concern (2024)

Lack of Assurance of Sterility

Class II

1...48 495051 52...388

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Moderate

FDAJan 30, 2024Nationwide• Brassica Pharma Pvt Ltd

Lubricant PM Ointment (Brassica) – Sterility Concern (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 30, 2024Nationwide• Brassica Pharma Pvt Ltd

Equate Eye Ointment (Brassica) – Sterility Concern (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 30, 2024Nationwide• Brassica Pharma Pvt Ltd

BCID2 Panel (BioFire) – False Positive Results (2024)

Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums

FDAJan 26, 2024Nationwide• BioFire Diagnostics, LLC

FilmArray GI Panel (BioFire) – False Norovirus Results (2024)

Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.

FDAJan 26, 2024Nationwide• BioFire Diagnostics, LLC

I.B.S Compression Screw (In2Bones) – Batch Mix-up (2024)

This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.

FDAJan 26, 2024Nationwide• In2Bones, SAS 28 Chemin du petit Bois Ecully France

Ionolux (Voco) – Plunger Fitting Error (2024)

Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.

FDAJan 25, 2024IA, NY, PA +1 more• Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany

IonoStar Plus (Voco) – Plunger Fitting Error (2024)

FDAJan 25, 2024IA, NY, PA +1 more• Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany

Impression Coping (Thommen) – Canal Depth Issue (2024)

The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.

FDAJan 24, 2024Nationwide• Thommen Medical AG Eschenweg 3 Bettlach Switzerland

Norepinephrine Injection (Baxter) – Label Concentration Error (2024)

Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.

Class IIModerate

FDAJan 23, 2024Nationwide• Baxter Healthcare Corporation

Tensive Conductive Adhesive Gel (Parker) – Viscosity Complaint (2024)

Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.

FDAJan 22, 2024AZ, CA, FL +7 more• Parker Laboratories, Inc.

Glimepiride Tablets 1mg (Dr. Reddy's) – Tablet Misprint (2024)

Misprint on tablet

Class IIILow

FDAJan 18, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Glimepiride Tablets 1mg 500-count (Dr. Reddy's) – Tablet Misprint (2024)

Misprint on tablet

Class IIILow

FDAJan 18, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

W&H Surgical Handpiece (W&H) – Laser Marking Error (2024)

1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead it reads 1:1 on the body of the handpiece

FDAJan 16, 2024Nationwide• W & H DENTALWERK BUERMOOS GMBH Ignaz Glaser Strase 53 53 IGNAZ-GLASER-STRASSE BUERMOOS Austria

Fosfomycin Tromethamine Granules (Ascend) – Impurity Specification (2024)

Failed Impurities/Degradation Specification: Out of specification for organic impurities

Class IIModerate

FDAJan 16, 2024Nationwide• Ascend Laboratories, LLC

Directional Laser Probe (D.O.R.C.) – Fiber Extension Problem (2024)

When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely.

FDAJan 15, 2024Nationwide• D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands

Organic Trek Mix (Woodstock Farms) – Foreign Material (2024)

Product contains stem / vegetation foreign material.

Class IIModerate

FDAJan 12, 2024MD, MA, OR• United Natural Trading Inc. dba Woodstock Farms

Methylfolate Chewables (Bluebonnet) – Label Error (2024)

Label error during reprint. Says 1000 mg instead of 1000 mcg on the center front panel of the label.

Class IIILow

FDAJan 12, 2024Nationwide• Bluebonnet Nutrition Corporation (Dairy Ashford)