Enforcement Report - Week of September 5, 2012
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Event Detail
| Event ID | 62572 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Phadia US Inc |
| City | Portage |
| State | MI |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-02 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | USA Nationwide. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| PHADIA VarelisA Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies) | Article Number 15696 Lot number #0067 | Class III | 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 the pre-wash step, when combined with a change in material source in kit lot #0067, caused elevated results. | 837 kits (96 assays per kit), total of 80,352 individual assays | Z-2285-2012 |
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