[Recalled] bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412623 Software update for the clinical instrument which is most commonly used to isolate
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412623 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients tha |
|---|---|
| Brand / manufacturer | Biomerieux Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0305-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 16 October 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
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 →
Related recalls from Biomerieux Inc
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.