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U.S. Department of Health and Human Services

Enforcement Report - Week of January 30, 2013

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Event Detail

Event ID 63949
Product Type Devices
Status Ongoing
Recalling Firm Becton Dickinson & Co.
City Sparks
State MD
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-18
Initial Firm Notification of
Consignee or Public
Distribution Pattern USA including CT, FL, IL, KS, MD, MI, MO, NY, PA, RI, TX and WI. Internationally to Canada, Europe and Japan.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
BD MAX (tm) (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. Serial Numbers: MX0001 to MX0065 CM0001 to CM0105 NOTE: Serial numbers are assigned sequentially. The above ranges will include all sequential numbers in between the beginning and end points. Class II Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results. 86 Instruments Z-0701-2013