Below are an example of some MDA's we have published that are of particular relevance to pathologists. To see a complete list of our MDAs, please visit the Medical Device Alert section of our website.
To receive the alerts previously sent to you by the former Commission for Social Care Inspection (CSCI) (now part of the Care Quality Commission) please complete the CAS contact details form 
(29Kb) and return it to safetyalerts@dh.gsi.gov.uk
Pathology-related Medical Device Alerts
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08 May 2012 | Medical Device Alert: Alaris® IVAC® 590 series blood set manufactured by CareFusion (MDA/2012/023)
This Medical Device Alert has been issued as the MHRA has been informed that the manufacturer has received reports of leakage between the sleeve tubing and the drip chamber joint of the blood set when using Alaris® IVAC® 590 series blood sets.
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29 Mar 2012 | Medical Device Alert: Sterile indigo carmin manufactured by Derm Tech (MDA/2012/015)
This Medical Device Alert has been issued after the manufacturer identified that indigo carmin dye manufactured sterile may change to an unexpected colour and/or exhibit a weak colour.
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20 Feb 2012 | Medical Device Alert: Histology laboratory reagents: Primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15). Labelled NovocastraTM and BondTM both manufactured by Leica Biosystems (MDA/2012/006)
This Medical Device Alert has been issued as there is a risk of misclassification of lymphoma tumours and subsequent delay to diagnosis or delayed or inappropriate treatment.
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09 Feb 2012 | Medical Device Alert: Reagents requiring manual handling for use in combination with Cobas c501/502 analyser manufactured by Hitachi (MDA/2012/004)
This Medical Device Alert has been issued because the use of insufficient volumes of reagent may lead to a false negative result leading to patient harm.
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28 Nov 2011 | Medical Device Alert: Blood glucose analyser manufactured by HemoCue AB (MDA/2011/107)
This Medical Device Alert has been issued in relation to the Blood glucose analyser, Glucose 201+, as there is potential for missed hyperglycaemia if you are using this machine with outdated software.
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03 Nov 2011 | Medical Device Alert: Laboratory based syphilis test: Mercia Syphilis M kit manufactured by Microgen Bioproducts Limited (MDA/2011/104)
This Medical Device Alert has been issued as higher level of non-specific cross-reactivity leading to false positive syphilis IgM results there may be misdiagnosis of early acute infection.
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07 Jun 2011 | Medical Device Alert: Alcohol skin preparation pads, swabs and swabsticks manufactured by Triad Group Inc since 2007 (MDA/2011/065)
This Medical Device Alert has been issued because the manufacturers published Field Safety Notices (FSN) for these devices in April 2011, but have not had sufficient confirmation from users that they have received and acted on this information.
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17 May 2011 | Medical Device Alert: Powder free examination gloves manufactured by BM Polyco Ltd (MDA/2011/049)
This Medical Device Alert has been issued as gloves from the affected lots may have pinholes, which could increase the risk of cross infection and leakage.
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12 May 2011 | Medical Device Alert: Blood glucose meters for professional use only: StatStrip Glucose manufactured by Nova Biomedical (MDA/2011/044)
This Medical Device Alert has been issued because the meter may generate consecutive error codes for multiple samples from the same patient, which may mask abnormal glucose levels.
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11 May 2011 | Medical Device Alert: Biogel Eclipse Reveal surgical gloves manufactured by Molnlycke Health Care (MDA/2011/043)
This Medical Device Alert has been issued as the company has received a small number of reports from customers overseas that pinholes have been found on the package seal of the Biogel Eclipse Reveal gloves. No reports have originated from the UK.
