Enforcement Report - Week of January 30, 2013
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Product Detail
| Product Description | 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. |
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| Recall Number | Z-0701-2013 |
| Classification | Class II |
| Code Info | 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. |
| Product Distributed Qty | 86 Instruments |
| Reason For Recall | Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results. |
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 | Letter |
| Distribution Pattern | USA including CT, FL, IL, KS, MD, MI, MO, NY, PA, RI, TX and WI. Internationally to Canada, Europe and Japan. |
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