Device product
Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.
Z-0701-2013
Product summary
- 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
Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.