Amplicor Detection Internal Control 의 리콜

Recall

2004-07-12

France

ANSM

https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-dmdiv-amplicor-de-par-roche-diagnostics

Roche Diagnostics withdraws the lots from the market. E13115 (version 31.07.05) of the in vitro diagnostic medical device called Amplicor Detection Internal Control - reference 207 633 06. E13307 (March 30, 2009) of the in vitro diagnostic medical device called Amplicor Mycobacterium tuberculosis detection (MTB) - reference 207 574 62. E11231 (version 30.09.04) of the in vitro diagnostic medical device called Amplicor HIV-1 Monitor v1.5 - reference 211 177 5. following the demonstration of the potential appearance of a blue precipitate during use of the conjugate Peroxidase-Avidin (AV-HRP) / lot E09659 contained in these batches .. The results returned with these lots are considered correct and valid. However, this precipitate can, in rare cases, increase the background noise in the Amplicor MTB device and result in lower positive results; the weakly positive results should be reviewed and reinterpreted according to the clinical data (according to the instructions). These devices use a molecular biology technique (PCR: Polymerase Chain Reaction) for the qualitative or quantitative research of specific nucleic acids. .. Amplicor Detection Internal Control is used with the manual Amplicor MTB Detection Kit for the detection of Mycobacterium tuberculosis. Amplicor HIV-1 Monitor v1.5 is a manual kit for the determination of HIV-1 RNA, used in the treatment of patients infected with HIV-1, known.