Drug recall
HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged…
FDA recall event 71804 · Class II · Hardy Diagnostics
Key facts
| Event ID | 71804 |
|---|---|
| Recall numbers | Z-2463-2015 |
| Recalling firm | Hardy Diagnostics |
| Product type | Devices |
| Products | HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot. |
| Initiation date | Jul 9, 2015 |
| Report date | Sep 2, 2015 |
| Termination date | Nov 10, 2015 |
| City | Santa Maria |
| State | CA |
| Country | United States |
| FEI number | 2022807 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: