Field Safety Notice Alpha Solway Face Fit Test Solution A and Face Fit Test Solution B 50ml Bottles Saccharin and Bitrex (ICN 3232)

NHSSC: 101

Alert:

• Alpha Solway has issued a Field Safety Notice dated 16 January 2026 having identified a quality issue affecting AlphaSolway™ Face Fit Test Solution A and AlphaSolway™ Face Fit Test Solution B (50 ml bottles, Saccharin and Bitrex).
• Alpha Solway observed in some products, visible premature degradation over time, including discolouration and/or particulate. This can result in the reduction of the declared shelf life.
• This notification affects products whose shelf life expires between 7 March 2026 and 19 February 2028.
• The company advise Microbiological screening (culture) has been carried out and no trace was found of waterborne pathogens, Legionella, E.coli, Coliforms, Enterococci or Clostridia. Subsequent findings indicate predominantly a yeast contamination, most likely derived from environmental exposure.

Products Affected:

• The products affected have been supplied by NHS Supply Chain:

• Alpha Solway advise a comprehensive corrective action plan has been implemented to ensure that the quality issue is resolved.
• Future orders will be fulfilled with unaffected stock.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all the affected products.
• Dispose of the affected products in accordance with your local regulations. Globus will replace the affected products with shelf life expiry dates between 7 March 2026 and 19 February 2028 at no charge.
• To arrange free of charge replacements please contact the Globus Customer Service Team before 1 March 2026 by either emailing: sales@globusgroup.com or telephoning 0161 877 4747.
• Please also contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products for replacement, including product code, expiry dates and quantity. Your Customer Services Advisor will give you a unique CMS log number, which should be quoted if you require further help.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Acute team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.