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Ref: MDA/2010/016
Device
Pregnancy test for professional use.
Clearview hCG Combo
manufactured by Unipath Limited.
Product code 506760.
Distributed between July 2008 and
August 2009.
Problem
Action
False positive results may be observed when
the test results are interpreted after:
• 3 minutes for urine samples
• 5 minutes for serum samples.
Specific product lot numbers contain
instructions for use that have since been
updated.
• Destroy, or return to the manufacturer,
devices from affected lot numbers.
• Ensure that all users read results at 3
minutes for urine samples and 5 minutes
for serum samples, and are aware of
revised instructions for new products.
• Use a timer, stopwatch or clock as
recommended in the instructions. Tests
read before or after the read time should
be repeated.
• Ensure standard operating procedures
(SOP) are updated to reflect
manufacturer’s revised instructions.
Action by
Healthcare professionals using or distributing
this device.
Healthcare personnel treating patients based on
results from these kits.
CAS deadlines
Contact
Action underway: 22 March 2010
Action complete: 06 April 2010
Manufacturer
Mrs Lesley Paice
Unipath Limited
Tel: 01234 835 530
Email: lesley.paice@invmed.com
Device
Distributor: Inverness Medical UK.
Lot numbers: HCG7110050; HCG8080019; HCG8090063; HCG8100213; HCG8100214; HCG8120013;
HCG8120232; HCG9020164; HCG9040093; HCG9060014.
This test is intended for professional use only. It is not intended for home use.
It is intended for use with either urine or serum.
Problem
Since issuing MDA/2009/054 for Clearview hCG, the manufacturer has updated the instructions for use for
Clearview hCG Combo and is recalling all lots containing instructions for use issued prior to the change in
read time. The instructions for use have been changed from a read time of 3–10 minutes, to 3 minutes only
for urine, and from 5–10 minutes, to 5 minutes only for serum. This was communicated by a Field Safety
Notice issued in November 2009. Reading results before or after the read time may lead to false positive
results in samples with a low level of hCG.
The MHRA has not received any complaints regarding reading times in this device and the changes in read
time were as a result of internal manufacturer investigations.
The MHRA has published a guidance leaflet ‘Pregnancy Testing Top Tips’, which covers issues such as
training and the importance of ensuring that devices are read at the correct time.
Distribution
This MDA has been distributed to:
• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Chief Executives)
• Primary care trusts in England (Chief Executives)
Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. |
