FDAFDA · Food and drugs·Recall number Z-1055-2017
Digital RID Plate Reader and Software Product Code: AD400
Published January 25, 2017 · Recall initiated: October 9, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
If a control ring is marked after reading, the software will not flag results that are out of the specified QC range.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Binding Site Group, Ltd.
- Distributor
- 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.
- Lot
- UDI 05051700000376
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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