Reported Dec 19, 2012 · Terminated
DataCara GM is an information management system that provides data management functionality for managing blood glucose…
Roche Molecular Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Molecular Systems, Inc. · 1080 Us Highway 202 S · Branchburg, NJ · 08876-3733
Is this the product you have?
- DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
- Lot codes and dates
- Device-associated diagnostic software
- Amount recalled
- 479 units
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
Why it was recalled
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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