Enforcement Report - Week of September 5, 2012
-
Back to Previous Page
Product Detail
| Product Description | PHADIA VarelisA Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies) |
|---|---|
| Recall Number | Z-2285-2012 |
| Classification | Class III |
| Code Info | Article Number 15696 Lot number #0067 |
| Product Distributed Qty | 837 kits (96 assays per kit), total of 80,352 individual assays |
| 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 the pre-wash step, when combined with a change in material source in kit lot #0067, caused elevated results. |
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. |
-
