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Clinitest® hCG

Notice type: Advisory

Date: 19/12/2011

  

Product name or type:
Clinitest® hCG

Reference:
SN2011(33)

Manufacturer Or Supplier:
Siemens Healthcare Diagnostics (Manufacturer) 
Cruinn Diagnostics Limited (Distributor)

Target Audience:
Accident & Emergency Departments 
Chemotherapy Nurses / Consultants 
Day Surgery / Endoscopy Units 
Directors of Anaesthetics 
Family Planning Clinics 
General Practitioners 
Health Service Executive 
Hospital Chief Executive Officers 
Medical Directors 
Nursing Executive Directors 
Laboratory Managers 
Obstetrics and Gynaecology Consultants / Departments 
Oncology / Radiotherapy Departments 
Pharmacy Departments 
Point of care Managers / Coordinators 
Procurement Departments 
Relevant Wards 
Risk Managers 
Theatre Managers 
X-Ray Departments 

Problem Or Issue:
Lots 028619, 028924, 029997, 030240, 030431, 030602, 030826, 030998, 031332, 031460, 031662, 031798, 031924, 032106 and 032180 of the Clinitest hCG pregnancy test kits have been recalled by the manufacturer due to the potential for borderline or false positive results with commercially available controls and patient samples.

Background Information Or Related Documents:
The Clinitest hCG pregnancy test kit is intended for professional use only in hospitals / clinics and is not sold in pharmacies for home use. The Clinitest hCG pregnancy test may be carried out to: 

a) Determine pregnancy 
b) As part of the investigation of certain patient symptoms 
c) To rule out pregnancy before treatments or procedures that are contraindicated or should be avoided by pregnant women e.g. diagnostic x-rays. 

Siemens Healthcare Diagnostics are recalling 15 lots (listed above) of Clinitest hCG pregnancy test kits following confirmation of potential borderline or false positive results with commercially available negative controls and patient samples.

Clinitest® hCG Document

Actions To Be Taken:
ACTION OR RECOMMENDATIONS FOR HEALTHCARE PROFESSIONALS 
• Ensure that all relevant staff in your institution are informed of this 
recall 
• Determine if you have lots 028619, 028924, 029997, 030240, 030431, 
030602, 030826, 030998, 031332, 031460, 031662, 031798, 031924, 
032106, and 032180 of the above product 
• Locate and cease using product from the lots listed above 
• Determine how much of this product has been used 
• Follow the distributor / manufacturers recommendations for quarantine 
and disposal of product 
• Follow up with patients as required. 


ACTION OR RECOMMENDATIONS FOR PATIENTS 
• Patients who have had a recent pregnancy test administered by a healthcare 
professional but are concerned that the positive result received may be 
incorrect should contact or seek a retest from their GP, family planning 
clinic or pharmacist. 

Further Information:
Enquiries to the distributor should be addressed to: 

Cruinn Diagnostics Ltd, 
5b/6b Hume Centre, 
Parkwest Industrial Estate, 
Nangor Road, 
Dublin 12 
Ireland 

Telephone: +353-1-6297400 
Fax: +353-1-6297401 
E-mail: sean.mcgeown@cruinn.ie 
Website: www.cruinn.ie 

Enquiries to the manufacturer should be addressed to: 

Siemens Healthcare Diagnostics Ltd, 
Sir William Siemens Square, 
Frimley, 
Camberley GU16 8QD, 
England 

Telephone: 0044 (0) 1908 487600 
Fax: 0044 (0) 1908 487601 
Email:  Anthony.walsh@siemens.com


All adverse incidents relating to a medical device should be reported to the: 

Health Products Regulatory Authority
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 

Telephone: +353-1-6764971 
Fax: +353-1-6344033 
E-mail: devicesafety@hpra.ie
website: www.hpra.ie

Please click here to download a PDF version of this Safety Notice

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