Version 1.2.0 of Accu-Chek Connect Diabetes Management recall: Software Issue
Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
Why was Version 1.2.0 of Accu-Chek Connect Diabetes Management recalled?
Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due to the software containing a programming error (bug) in the Bolus Advisor feature, which could lead to an incorrect insulin bolus recommendation.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016; Catalog number 07562462001 / GTIN number 00365702700000
- Product
- Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
- Recalling firm
- Roche Diabetes Care, Inc.
- Quantity
- 7,909 downloads of iOS version 1.2.0 of the Accu-Chek Connect Diabetes Management App in the US and 8,775 downloads Internationally
- Distribution
- US Distribution to the states of : Alabama, Arizona, Arkansas, California, Colorado, Connecticut, DC, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin Foreign: None provided
- Recall date
- November 23, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)