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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 4661–4680 of 10937 recalls

Calibration Serum (Randox) – targets realignment (2019)

Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).

Moderate

FDAJul 12, 2019Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Neomycin Ophthalmic Solution (Pharma Pac) – Quality Control Failure (2019)

CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.

Class IIModerate

FDAJul 12, 2019CA, IN• H J Harkins Company Inc dba Pharma Pac

Double Dutch Muffin (Brill) – Plastic Contamination (2019)

Frozen, unbaked muffins potentially contaminated with small pieces of plastic.

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Class II

Moderate

FDAJul 12, 2019CA, IN, IA +5 more• Brill, Inc., a CSM Bakery Solutions Company - Atlanta Ingredients

MDM Poppy Seed Muffin (Brill) – Plastic Contamination (2019)

Frozen, unbaked muffins potentially contaminated with small pieces of plastic.

Class IIModerate

FDAJul 12, 2019CA, IN, IA +5 more• Brill, Inc., a CSM Bakery Solutions Company - Atlanta Ingredients

Drospirenone Ethinyl Estradiol Tablets (Jubilant Cadista) – Failed Dissolution (2019)

Failed dissolution specifications : failed results at the 3-month stability time point.

Class IHigh

FDAJul 9, 2019Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

BD FACS Sample Prep Assistant (BD Biosciences) – probe wear (2019)

The recalling firm confirmed that BD FACS Sample Prep Assistant (SPA) II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use (IFU). When the probe is worn, particles from the rubber cap are more likely to clog the probe, resulting in blocked or inadequate sample dispense.

Low

FDAJul 8, 2019Nationwide• Becton, Dickinson and Company, BD Biosciences

GammaPod Radiotherapy System (Xcision) – motor bolt alignment (2019)

One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.

Low

FDAJul 3, 2019MD, TX• Xcision Medical Systems, LLC

Blanketrol III (Cincinnati Sub-Zero) – Tissue Damage Warning (2019)

Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes

High

FDAJul 2, 2019Nationwide• Cincinnati Sub-Zero Products LLC, a Gentherm Company

Blanketrol II (Cincinnati Sub-Zero) – Tissue Damage Warning (2019)

Low

FDAJul 2, 2019Nationwide• Cincinnati Sub-Zero Products LLC, a Gentherm Company

CoolBlue Hyper-Hypothermia (Cincinnati Sub-Zero) – Tissue Damage Warning (2019)

Low

FDAJul 2, 2019Nationwide• Cincinnati Sub-Zero Products LLC, a Gentherm Company

Universal Sexual Health Kit (PrivaPath) – Tube Damage (2019)

A supplier informed PrivaPath Diagnostics that there is a potential for damaged tubes which could result in blood exposure or erroneous results due to an inappropriate blood-to-additive ratio.

Low

FDAJul 1, 2019Nationwide• Privapath Diagnostics Ltd Unit A10 Block A Calmount Park; Calmount Avenue Dublin

Paradigm Veo Pump (Medtronic) – Cybersecurity Vulnerability (2019)

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

High

FDAJun 27, 2019Nationwide• Medtronic MiniMed

This recall involves Venus Simply3 disposable razors. The razors come in pink, purple, and yellow colors and were sold in two types of packages: a Venus Simply3 Disposable Razor 4-pack and a Daisy 12+1 Venus Simply3 Bonus Pack which included one free Venus Simply3 razor. The ten digit lot code can be found on the right or left side of the plastic package. The UPC number can be found inside the package adjacent to the bar code. Venus Simply3" - 4 count pack razors Lot numbers: 9003A17400 and 9007A17400 UPC: 047400315358 Daisy 12 + 1 Venus Simply3 razors Lot number: 9009A17400 UPC: 047400300712

Moderate

CPSCJun 27, 2019Nationwide• The Gillette Company LLC, of Boston, Mass.