PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody… — Class III medical device recall Z-2285-2012
Terminated recall by Phadia US Inc, reported 2012-09-05, distributed nationwide. Customers were not following the labeled assay procedure. This was due to a letter issued to them in 2004 from
| Recall number | Z-2285-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Phadia US Inc, Portage, MI, United States |
| Recall initiated | 2012-08-02 |
| Classified | 2012-08-28 |
| Reported by FDA | 2012-09-05 |
| Terminated | 2012-12-12 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, potency |
| Lot numbers | 0067 |
Product
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2285-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.