Binding Site Digital RID Plate Reader Recalled for Software Defect
The Binding Site Group is recalling Digital RID Plate Readers and software because a defect may prevent the system from flagging out-of-range quality control results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The defect involves a failure to flag quality control errors, which is a significant software issue but does not involve reported injuries or deaths, fitting the Moderate severity criteria for a Class II recall without hospitalization reports.
Plain-English summary
The Binding Site Group, Ltd. is recalling the Digital RID Plate Reader and Software (Product Code: AD400) under FDA recall number Z-1055-2017. The recall is due to a software defect where, if a control ring is marked after reading, the software fails to flag results that are outside the specified quality control range.
The affected products were distributed in the United States to Massachusetts, Georgia, New York, Iowa, California, Illinois, Utah, New Jersey, North Carolina, Maryland, and Minnesota. Foreign distribution included the United Kingdom, Germany, Spain, and France. The specific UDI for the affected units is 05051700000376.
Users of the affected equipment should contact The Binding Site Group, Ltd. for further instructions regarding the recall and potential remediation of the software issue.
The recalled product
- Product
- Digital RID Plate Reader and Software Product Code: AD400
- Manufacturer
- The Binding Site Group, Ltd.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI 05051700000376
Distribution
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