FDA Device recall Z-2285-2012
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
- FDA Device
- Class III
- terminated
- Published 2012-09-05
On 2012-09-05 the FDA classified a Class III recall of PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies) by Phadia Us, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2285-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-08-02 |
| Published | 2012-09-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Phadia Us |
| Distribution | US |
Product
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Reason
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.
Identifiers
| code_info | Article Number 15696 Lot number #0067 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2285-2012%22
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