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Clinitest® hCG Cassette Pregnancy Test Kit

Notice type: Recall

Date: 15/04/2008

  

Product name or type:
Clinitest® hCG Cassette Pregnancy Test Kit

Reference:
SN2008(05)

Manufacturer Or Supplier:
Siemens Healthcare Diagnostics (Manufacturer) 
Allphar Services 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:
Lot 97552 and lot 97574 of the Clinitest hCG pregnancy test kits has been recalled by the manufacturer due to the potential for false negative results i.e. a negative result obtained in pregnancy.

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:   

  • Determine pregnancy 
  • As part of the investigation of certain patient symptoms 
  • To rule out pregnancy before treatments or diagnostic x-rays / procedures that are contraindicated or should be avoided by pregnant women  
Siemens Medical Solutions Diagnostics are recalling lot 97552 and lot 97574 of Clinitest hCG pregnancy test kits following identification of a manufacturing defect. The manufacturer reports that the sensitivity of the reagent with Clinitest hCG lot 97552 and lot 97574 has decreased and that this decrease in sensitivity has the potential to generate false negative hCG results. The shelf life of lot 97552 and lot 97574 is impacted by the shift in sensitivity and can no longer guarantee.   

The Irish Medicines Board (IMB) has been advised by the Irish distributors that all public and private hospitals / clinics that have received the affected lot have been advised of this recall.

Clinitest® hCG Cassette Pregnancy Test Kit 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 lot 97552 and lot 97574 of the above product
  • Locate and cease using product from lot 97552 and lot 97574
  • Determine how much of this product has been used
  • Follow the distributor / manufacturers recommendations for quarantine and disposal of product
  • Follow up patients as required  
Action or Recommendations For Patients
  • Patients who have had a recent pregnancy test in hospital but are concerned that the negative result received may be incorrect should contact or seek a retest from their GP, family planning clinic or pharmacist

Further Information:
Enquires to the manufacturer should be addressed to: 

Siemens Medical Solutions Diagnostics Europe Limited 
Chapel Lane 
Swords 
Co. Dublin   

Telephone:        +33 1 49229905 
Fax:                  +33 1 49223248 
Email:               sylvie.legledic@siemens.com

United Kingdom Branch   

Telephone:        1800 409 904 
Fax:                  +44 1276 696680 
Email:               dx-npt_helpdesk-uk.med@siemens.com   

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

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

If you have any enquiries, you may contact the Medical Devices Department at:   

Telephone:        +353-1-6764971 
Fax:                  +353-1-6344033 
Email:               vigilance@imb.ie 
Website:            www.hpra.ie  

SN2008(05) - Clinitest® hCG Cassette Pregnancy Test Kit

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