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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

582

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 1601–1620 of 10937 recalls

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

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

1...79 808182 83...547

Page 81 of 547Next

Aquilex Fluid System (WOM) – Volume Display Limit (2023)

The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid overload

High

FDAJul 17, 2023Nationwide• WOM World Of Medicine AG Alte Poststr. 11 Ludwigsstadt Germany

Outshine Strawberry Fruit Bars (Dreyer's) – Milk Allergen Alert (2023)

Undeclared Allergen

Undeclared allergen; milk.

Class IIModerate

FDAJul 17, 2023AL, AR, DE +14 more• Dreyer's Grand Ice Cream, Inc.

L-Aneurysm Clip (Peter Lazic) – Incorrect Color (2023)

Wrong product coloring. The paddle clips should be blank, but they are colored blue.

Low

FDAJul 14, 2023Nationwide• Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany

MobileLink Acetabular Cup (Waldemar Link) – Incorrect Offset (2023)

Product is labeled with incorrect offset.

Low

FDAJul 14, 2023AL, NV, NJ• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Plum 360 Infusion System (ICU Medical) – Alarm Signal Issue (2023)

Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.

High

FDAJul 13, 2023Nationwide• ICU Medical Inc

Testosterone Injection (New Vitalis) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 13, 2023Nationwide• New Vitalis Pharmacy LLC dba New Vitalis Pharmacy

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K (Medtronic Sofamor Danek USA, Inc) – incorrect laser marking - solera awl ... (2023)

Incorrect Laser Marking - Solera Awl Tip Tap

Low

FDAJul 12, 2023Nationwide• Medtronic Sofamor Danek USA, Inc

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

Succinylcholine Chloride Syringe (Advanced Compounding) – Production Contamination (2023)

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

Class IIModerate

FDAJul 10, 2023Nationwide• New England Life Care, Inc. dba Advanced Compounding Solutions

Rocuronium Bromide Syringe (Advanced Compounding) – Production Contamination (2023)

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

Class IIModerate

FDAJul 10, 2023Nationwide• New England Life Care, Inc. dba Advanced Compounding Solutions

Vancomycin IV Bag (Advanced Compounding) – Production Contamination (2023)

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

Class IIModerate

FDAJul 10, 2023Nationwide• New England Life Care, Inc. dba Advanced Compounding Solutions

Phenylephrine HCl IV Bag (Advanced Compounding) – Production Contamination (2023)

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

Class IIModerate

FDAJul 10, 2023Nationwide• New England Life Care, Inc. dba Advanced Compounding Solutions

Hand Sanitizer (Big Machine Distillery) – Impurity Excess (2023)

CGMP Deviation: impurities exceed allowable limits.

Class IIModerate

FDAJul 10, 2023TN• Tenn South Distillery LLC dba Big Machine Distillery

LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP Sys... (Alphatec Spine, Inc. 1950 Camino Vida Roble) – awl instrument adjustable drill butto... (2023)

Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, increased operative time, revision surgery.

High

FDAJul 7, 2023Nationwide• Alphatec Spine, Inc. 1950 Camino Vida Roble

Medtronic InterStim Ground Pad REF 041826 (Medtronic Neuromodulation) – lot of interstim self-adhesive ground... (2023)

Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.

Low

FDAJul 6, 2023Nationwide• Medtronic Neuromodulation

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size ... (Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany) – increased force may be required to re... (2023)

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

Moderate

FDAJul 3, 2023Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Wireless Foot Switch distributed with Philips Allura Xper... (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands) – loss of availability of the wireless ... (2023)

Loss of availability of the wireless foot switch during procedures.

Moderate

FDAJun 30, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands