Based on the information provided, a user error has caused the adverse event.Leica biosystems nussloch has been alerted the customers, not to use flammable freezing spray with the cryostat, since (b)(6) 2019.The affected customer has used a flammable freezing spray from the manufacturer "cardinal", although it was prohibited with clear instruction with part of the field action (reference number of the field action: z-1729-2019) with a clearly visible warning label and update of ifu with detailed explanation and warning hint.He was initially informed about the field action notice with the recall letter and small sticker on (b)(6) 2019 and has also responded with completed recall acknowledgement form on (b)(6) 2019.Afterwards, the larger sticker with additional text and the recall letter has been sent to this customer on (b)(6) 2019 as well.The customer responded the second time with completed recall acknowledgement form on (b)(6) 2019.However, the customer never changed their freeze spray after the recall letter, safety amendment of the instructions for use and the sticker was provided.After the completion of the field action, we had globally no other repeated incident.Because this is a single occurrence, the decision was that no further measures are required in the field.
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