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Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom

Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom Recalls

All product recalls associated with Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom.

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Recall Summary

Total Recalls

343

Past Year

Class I (Serious)

Most Recent

Oct 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 181–200 of 343 recalls

Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom: Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGEN...

There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

FDASep 16, 2019Nationwide• Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom

Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China: Positron Emission Tomograpy and Computed Tomography Syste...

Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose.

FDAAug 26, 2019Nationwide• Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China

Rocket Medical Plc Industrial Estate Sedling Road Wear Indu Tyne & Wear Washington United Kingdom: Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

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A complaint was received regarding kinking of the device prior to use. If a device is kinked it cannot be used. In addition, the company became aware that the device had been used for pleural drainage, which is not included in the device indications.

FDAAug 1, 2019Nationwide• Rocket Medical Plc Industrial Estate Sedling Road Wear Indu Tyne & Wear Washington United Kingdom

Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China: Digital Medical X-ray Imaging System, Model: uDR 596i, uD...

X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure.

FDAJul 30, 2019Nationwide• Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China

Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom: RX Imola, Model Nos. RX4900

There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument.

FDAJun 24, 2019CA, CT, MD +10 more• Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom

Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom: RX Daytona, Model Nos. RX4040 and RX4041

There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument.

FDAJun 24, 2019CA, CT, MD +10 more• Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom

Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom: Human Assayed Multi-Sera Level 2, Model NO. HN1530 Pro...

The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.

FDAJun 11, 2019Nationwide• Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom

Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom: Assayed Bovine Multi-Sera Level 1, Model No. AL1027

The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.

FDAJun 10, 2019AZ, OR, VA +2 more• Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom

Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom: Quantum Pump Console

Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.

FDAMay 29, 2019NY, OH, VA +1 more• Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom

Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom: Aquarius D13S319 Plus Deletion Probe, Model LPH068-A P...

There is an error in the chromomap on the package insert.

FDAApr 26, 2019Nationwide• Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom

Tyvaso Inhalation System (United Therapeutics) – Defective Device (2018)

Defective Delivery System: Water ingress through the lower water cup sensor of the device.

Class IIILow

FDAAug 14, 2018IL, PA• United Therapeutics Corp.

Naked Bread Hamburger Buns (United States Bakery) – Undeclared Milk (2018)

Undeclared Milk

Naked Bread Hamburger Buns #NothingToHide, 8 pack, are recalled due to undeclared milk.

Class IHigh

FDAJul 2, 2018CA, ID, IN +4 more• United States Bakery Corp

Zhong Hua Jiu Patch (United Pacific) – CGMP Deviation (2018)

CGMP Deviations: the product was produced with substandard GMP manufacturing processes.

Class IIModerate

FDAMar 29, 2018Nationwide• United Pacific Co Ltd