The Binding Site Group, Ltd. recalls Digital RID Plate Reader and Software Product Code: AD400
- Recall date
- October 9, 2012
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1055-2017
- FDA classification
- Class II
- Brand / firm
- The Binding Site Group, Ltd.
- Sold / distributed
- 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.
Why it was recalled
If a control ring is marked after reading, the software will not flag results that are out of the specified QC range.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Digital RID Plate Reader and Software Product Code: AD400
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