Roche Recalls Accu-Chek Inform II Base Units Due to Data Loss Risk
Roche is recalling Accu-Chek Inform II Base Units because they may lose data or mismatch patient records when connected to specific Data Management Systems.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the hazard is data integrity failure leading to potential patient mismatch, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling the Accu-Chek Inform II Base Unit, which is part of the Accu-Chek Inform II Blood Glucose Monitoring System. The system is intended for in vitro diagnostic use in professional healthcare settings. The recall involves 5,604 devices in the United States and 91,925 devices outside the United States.
The recall is being issued because the base unit might produce physical transmission errors, resulting in data loss during communication between the meter and Data Management Systems (DMS). In the worst case, this issue could lead to an erroneous assignment of patient data, also known as patient mismatch. This specific issue only occurs at sites using POTCT1-A communication via USB.
The affected devices are identified by Model/Catalog/Part Number 05060290001 and serial numbers ranging from UU41000000 through UU41064963 and UU41064964 through UU41122741. The devices were distributed nationwide in the United States, including Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia.
The recalled product
- Product
- Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional heal
- Manufacturer
- Roche Diagnostics Operations, Inc.
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)
- Model/Catalog/Part Number: 05060290001
Distribution
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