Epiclone Anti N BGR - Immunohaematology Reagent. An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2017-RN-00754-1

Class II

2017-08-30

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00754-1

Seqirus received a report from a customer that lot 009934602 presented false positive results during pre-acceptance testing (cells known to be n negative phenotype presented positive results during tube testing). this was subsequently confirmed to have occurred for multiple customers.Additional customer feedback was also received for a separate epiclone anti n lot (009934501) where the customer reported the product to be “uncharacteristically sticky”, causing red cells to adhere to the inner surfaces of the tube (tube testing technique), resulting in difficulty to confirm whether the reaction produced a positive or negative result.Following these customer reports, investigational testing on all epiclone lots within expiry was performed, which confirmed that epiclone anti n lots 009934401, 009934501, 009934602 and 009934701 are capable of presenting false positive results against certain n negative samples.

1.Quarantine all affected units from further use. 2. Package all quarantined units and label “For Drug Recall Attention (Authorised Recall Officer)” 3. Mark on the outside of each package the name of the organisation or institution returning the product. 4. Complete the Facsimile/Email Reply Form supplied with the customer letter and fax/email back to Seqirus Customer Service so that they may arrange for affected stock to be recovered, including if no product is in stock. 5. Seqirus will provide replacement of returned stock once alternative product is available. 6. Review previous results generated with the affected lot numbers as required.