Alerta De Seguridad para BD MAX MRSA Assay

Safety alert

2014-08-01

2014-08-01

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140801b.html

Medical device safety alert: bd max mrsa assay medical device manufacturer, bd diagnostic systems, has issued a medical device safety alert concerning its bd max mrsa assay [catalogue no.: 442953; unit: 24 each; lot no.: all lots with an expiration date of 2014-01-21 or later]. according to the manufacturer, their investigation of incorrect results related to the college of american pathologists (cap) surveys mrs5-a 2014 and mrs5-b 2014 using the bd-max mrsa assay confirmed that one of the samples for each of the surveys yielded some false positive results. initial analytical testing has demonstrated previously unobserved cross-reactivity due to non-specific binding with certain methicillin-sensitive staphylococcus aureus (mssa) strains, primarily when these organisms are present at high loads (> 1 x 106 cfu/swab). based on the manufacturer’s assessment of the likelihood of a false positive result, as well as documented performance at customer sites, the assay continues to meet clinical performance claims. while there is the potential for a false positive result for specimens from patients who are positive for certain strains of mssa when present at high loads, the manufacturer believes that such an occurrence is unlikely and overall clinical performance would not be affected. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 01 aug 2014.