Jan

2017

Digital RID Plate Reader Cl II

Company: The Binding Site Group, Ltd.
Date of Enforcement Report 1/25/2017
Class lI:

PRODUCT

Digital RID Plate Reader and Software Product Code: AD400
Recall Number Z-1055-2017

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

RECALLING FIRM/MANUFACTURER
The Binding Site Group, Ltd.Birmingham UK on 10/9/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

DISTRIBUTION
Nationwide and Internationally

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Digital RID Plate Reader Cl II

Amy Sellers

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