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Recall Observatory FDA recall evidence

Device product

Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.

Z-0701-2013

September 18, 2012

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 63949
Status
Terminated
Classification
Class II
Quantity
86 Instruments
Official record key
device-enforcement:Z-0701-2013

Official wording

Reason: Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.

Code information: 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.

Distribution pattern: USA including CT, FL, IL, KS, MD, MI, MO, NY, PA, RI, TX and WI. Internationally to Canada, Europe and Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.