Tag: mhra
Roche Diabetes Care test strip errors leads to recall
Roche Diabetes Care test strip errors has led to a recall of a number of home-use and point-of-care glucose monitoring systems.
The Roche Diabetes Care test strip errors are for the following systems: Accu-Chek Aviva; Accu-Chek Performa; and Accu-Chek Inform II.
There is a risk of a strip error message that may lead to either falsely high or falsely low blood glucose results reported.
Diabetes testing kit recall
News of a diabetes testing kit recall is said to be “urgent” amid fears of lives at risk over false readings.
The Accu-Chek Aviva and the Accu-Chek Performa are the diabetes testing kits being recalled that could lead to an overdose or an under-dose of insulin that can lead to serious health complications for users.
Advice to patients is to stop using the affected devices and return them to a pharmacy for a replacement.
Resuscitation system recall issued after risk of damage to lungs found
An error with a resuscitation system has been reported to risk damage to lungs, according to information released by the Medicines and Healthcare Products Regulatory Agency (MHRA).
Manufactured by Intersurgical, the manual resuscitation system – named as the “Bag valve mask” (BVM) – risks damage to lungs due to the potential for excess pressure being delivered by the system.
Given that the defect is with a resuscitation system, this recall is an important one as lives may be at risk as a result of it.
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MHRA announce recall of rectal / pharyngeal temperature sensors
Rectal / pharyngeal (orally inserted) temperature sensors manufactured by Teleflex are a part of a recent recall published by the Medicines and Healthcare Regulatory Authority (MHRA).
The issue with the devices may lead to a misdiagnosis where an inaccurate temperature reading is noted by a medical professional.
With body temperatures often being pivotal to medical diagnosis, this recall is a serious one where patients may be at risk of incorrect advice and treatment off the back of inaccurate temperature readings.
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Aquilon nebulisers – CE mark withdrawn and supply ceased, but many have remained on the market
Despite withdrawal of the CE safety marking for Aquilon series of nebulisers, manufactured by AFP Medical, the nebulisers have still been placed on the market. A number of devices may have been sold despite the withdrawal of the CE marking, which means the safety of the product cannot be guaranteed.
CE safety certification is vital for consumer and supplier confidence in a product, and when it comes to medical products, such approval – or withdrawal, as is the case here – can be even more important.
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UK government investigating the scale of harm caused by vaginal mesh implants
Our legal team have been assisting people in various situations involving harm caused by vaginal mesh implants.
The UK government review update is welcome news.
Years after the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) investigated issues and decided against recalls and bans, the National Institute for Health and Clinical Excellence (NICE) has suggested the surgery should be banned, and New Zealand have become the first country in the world to put an outright ban in place.
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MHRA issue “Class 4” drug alert warning for Focus Pharmaceuticals after barcode errors found on 8 medicinal products
The Medicines and Healthcare Products Regulatory Agency (MHRA) issued a Class 4 (caution in use) warning over eight Focus Pharmaceutical medicinal products after a problem was found with the barcodes.
The packaging fault may interfere with prescriptions as the wrong product may be identified when they’re scanned.
The medicines themselves have no reported faults and the rest of the packaging including the name, strength and pharmaceutical form of the medicine is correct as far as the manufacturer and the MHRA are aware.
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Class 4 drug alert for Kyowa Kirin Bleo-Kyowa Powder Solution
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug alert for the Bleo-Kyowa powder over a ‘minor’ defect being reported.
The agency cites glass particles being detected in a batch of the medicine back in April 2017.
Hospitals, pharmacies and other healthcare providers are requested to take caution in using the Bleomycin Sulphate powder that acts as an anticancer chemotherapy medicine.
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Ceftazidime antibiotic concentration may deteriorate if stored at the wrong temperature
The Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a medical device alert over the test disc for the antibiotic ‘Ceftazidime’, warning that storing the test discs at the wrong temperature can increase the chances of false resistance results.
The antibiotic is used to treat all sorts of bacterial infections including joint infections, sepsis, pneumonia, urinary tract infections and more. In cases where the Ceftazidime test disc was not frozen between the temperatures of +2o and -20o, notably at +8o, the antibiotic’s shelf-life may have been degraded.
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MHRA issues warning for Gentamicin Sulphate Active Pharmaceutical Ingredient over increased levels of histamine
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert over batches of Gentamicin Sulphate Active Pharmaceutical Ingredient (API) for trace contamination of histamine.
The situation is reportedly not serious enough to warrant a recall.
Gentamicin is a bactericidal used an as active ingredient for antibiotics. The MHRA was made aware that testing of the finished products has uncovered higher levels of histamine than expected. The unwanted histamine is thought to be a residual from the manufacturing process, with the potentially affected range between July 2014 and June 2017.
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