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

• The supplier Globus has informed us that the quality issue with its Alpha Solway Face Fit Test Solution A and Face Fit Test Solution B (50ml bottles, Saccharin and Bitrex) is continuing.
• BTP85030 is no longer available and is in the process of being delisted from our online catalogue.
• Eight affected product codes remain suspended and will be delisted from our online catalogue.
• 11 products remain affected in total.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.
• Please note that due to the clinical nature of these alternative products we advise you to consult your own clinical experts to ensure suitability for your organisations use of these products.

• Alpha Solway has issued a further Field Safety Notice dated 10 February 2026 extending the Product Recall to affect all packaging variants of the AlphaSolway™ Sensitivity Test Solution A and Facefit Solution B (Saccharin and Bitrex).
• Alpha Solway advises the decision follows an in-depth investigation into observed visible degradation over time, including discolouration and/or the presence of particulates in the 50ml bottles.
• They also confirm there are no concerns regarding stock that has already been used for its intended purpose, but future use must now cease.

 Products Affected:

• Six further products have been added to this Product Recall with all expiry dates now affected.
• 11 products are now affected in total.
• All affected products previously available via NHS Supply Chain are now unavailable to order, with all products suspended or deactivated and remaining stocks in our warehouses bonded.
• Please refer to the product listing for full details of the affected products and alternatives where applicable.
• Alpha Solway is currently seeking an alternative manufacturer or new product solution.
• This ICN will be updated as further information becomes available.

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.
• Contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products in your possession, including product code, lot numbers, and quantity. Your Customer Services Advisor will give you a unique CMS log number.
• Dispose of the affected products in accordance with your local regulations. Upon written confirmation of disposal in the form of an email, quoting the CMS reference, your Customer Services Advisor will raise the appropriate credit.

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.