Drug recall
The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct…
FDA recall event 68991 · Class II · Becton Dickinson & Co.
Key facts
| Event ID | 68991 |
|---|---|
| Recall numbers | Z-2618-2014 |
| Recalling firm | Becton Dickinson & Co. |
| Product type | Devices |
| Products | The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of 111 MSSA strains tested at extremely high… |
| Initiation date | Jul 23, 2014 |
| Report date | Sep 17, 2014 |
| Termination date | May 9, 2016 |
| City | Sparks |
| State | MD |
| Country | United States |
| FEI number | 1119779 |
At a glance
- 1–9 Products in this recall
- 10–99 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: