[Recalled] DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data. — Roche Molecular Systems, Inc | FDA 2012-07-16
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data. |
|---|---|
| Brand / manufacturer | Roche Molecular Systems, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0493-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 16 July 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.