medical Class II Updated 2018-11-07

Becton Dickinson & Co. recalls BD Max Instrument, Catalog Number 441916 441927 (refurbished

Recalled Product

BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The BD MAX System is also capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.


Hazard / Issue

A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vaginalis true positive.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: CTI1201-CTI1288
View official government recall

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