Company:Becton Dickinson & Co.
Date of Enforcement Report 1/30/2013
Class ll:
PRODUCT
BD MAX ™ (6 channel) Instruments, Catalog number 441916, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152 USA*** 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. The MAX reader assembly is the optics component of the instrument that translates PCR amplification into curves. The curves are evaluated by an algorithm when used with BD assays to interpret results. For open system reagent (OSR) users, the curve is evaluated manually to interpret the results based on their own validated criteria. The heater is part of an assembly that controls both the thermal cycling during the PCR reaction and the opening of the wax valves in the cartridge consumable. Recall Number Z-0701-2013
REASON
Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Co., Sparks, MD 9/18/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
86 Instruments
DISTRIBUTION
Nationwide and Internationally
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