Transport Swab Liquid Plain Amies FSN (ICN 1422)

MHRA TBA
NHSSC Ref: 52

Alert:

• Copan has received some reports of Bordetella parapertussis false positives observed at high cycle threshold values (Ct, Cycle threshold) when combining eSwab® with some in-house PCR protocols and the Pathofinder BV-RealAccurate Quadruplex Bordetella PCR kit.
• The investigation revealed the presence, inside the eSwab® device, of non-viable Bordetella parapertussis nucleic acid residues derived from raw materials used in the production process. These fragments can potentially be amplified with PCR methods, and in some cases, they could be detectable, giving false-positive results (weak positive at high Ct) depending on the analytical sensitivity of the commercial kit or the in-house protocol used.
• Since it is not currently possible to exclude the presence inside the eSwab® device of nucleic acid fragments coming from non-viable microorganisms other than Bordetella parapertussis, nor to exclude that these fragments are amplifiable and detectable with the combined use of eSwab® with PCR protocols, Copan considered it appropriate to integrate the instructions for use with a number of warnings and precautions. See our Downloads section to refer Field Safety Notice for full details.

Products Affected:

• All eSwab lots on the market with an expiry date on or before December 2022 are affect

ed.

• For details of the products available from NHS Supply Chain please see our Downloads section to refer to the product listing.

Next Steps:

• Copan has updated the instructions for use with warnings and precautions.
• Instigated corrective and preventative actions to reduce the risk of microbial nucleic acid fragments from raw materials.
• Customers need to read the Field Safety Notice, including the warnings and precautions, and share with all appropriate personnel.
• Complete and return the Reply Form by email to FSNRecalls@supplychain.nhs.uk as soon as possible, ideally within three days of receipt of this notice.

If you have any further questions, please contact Copan Customer Service by email FSN@copangroup.com or contact your local NHS Supply Chain Customer Service Advisor.