[Recalled] BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive ba
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448417 |
|---|---|
| Brand / manufacturer | Becton Dickinson & Co. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0761-2021 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 08 December 2020 |
| EAN / barcode | 00382904484170 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection
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 Becton Dickinson & Co.
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.
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