Drug recall
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
FDA recall event 62572 · Class III · Phadia US Inc
Key facts
| Event ID | 62572 |
|---|---|
| Recall numbers | Z-2285-2012 |
| Recalling firm | Phadia US Inc |
| Product type | Devices |
| Products | PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies) |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Customers were not following the labeled assay procedure. This was due to a letter issued to them in 2004 from Phadia GmbH, which indicated that customers could omit the pre-wash step. The omission of… |
| Initiation date | Aug 2, 2012 |
| Report date | Sep 5, 2012 |
| Termination date | Dec 12, 2012 |
| City | Portage |
| State | MI |
| Country | United States |
| FEI number | 3004973408 |
At a glance
- 1–9 Products in this recall
- None 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: