Field Safety Notice Protetanus Anti-Tetanus Antibody Assay FTM122 (ICN 2005)

MHRA TBC

NHS Supply Chain Reference: 84

Alert:

• Prospect Diagnostics Limited has issued a Field Safety Notice following one non-compliance report where the Protetanus platform was positioned upside down during the assembly of the platform.
• As a result, a pink band corresponding to the particle filter, usually hidden within the platform, became visible and could be interpreted as the (C) – Control band.
• This nonconformity remains easily identifiable by the ‘Point of Care’ practitioner when opening the platform ‘pouch’.
• Prospect Diagnostic advise there is no serious risk to the patient. A false negative result would give rise to a complementary vaccination for a potentially fully immunised patient.
• There is no possibility of a false positive result in this instance as no band can appear in the test zone (T) when interpreting the test.

Products Affected:

• The affected product is available from NHS Supply Chain:

• Please note only the batch number quoted is affected.
• All stock currently held by NHS Supply Chain are of different batch numbers. 

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Make note of the changed/ enhanced Instructions for Use (IFU).
• Reject any Protetanus platform if not compliant and email: Customercare@prosectdiagnostics.co.uk to arrange for replacement devices.
• Contact your NHS Supply Chain Customer Service Advisor with full details to enable us to assist in the exchange.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or Customer Relationship Manager.