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Recall Observatory FDA recall evidence

Device product

Digital RID Plate Reader and Software Product Code: AD400

Z-1055-2017

October 09, 2012

Class II

Product summary

Firm
The Binding Site Group, Ltd.
Event
Event 76043
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1055-2017

Official wording

Reason: If a control ring is marked after reading, the software will not flag results that are out of the specified QC range.

Code information: UDI 05051700000376

Distribution pattern: U.S. distribution to the following; MA, GA, NY, IA, CA, IL, UT, NJ, NC, MD, MN. Foreign distribution to the following; UK, Germany, Spain, France.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software will