FDA Medical Device Recalls (openFDA)
Phadia US Inc: PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
- Recall number
- Z-2285-2012
- Recalling firm
- Phadia US Inc
- Product
- PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
- Status
- Terminated
- Initiated
- 2012-08-02
- Posted
- 2012-08-28
- Terminated
- 2012-12-12
- 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.
- Root cause
- Labeling Change Control
- Action
- On 8/2/2012 an URGENT PRODUCT CORRECTION INFORMATION FOR PHADIA VARELISA CARDIOLIPIN IGM, Article Number 15696 letter was sent to all consignees the received the Direction for Use modification letter in 2004.
- Quantity
- 837 kits (96 assays per kit), total of 80,352 individual assays
- Distribution
- USA Nationwide.
- Lot, serial or model codes
- Article Number 15696 Lot number #0067
- 510(k) numbers
- ["K020758"]
- PMA numbers
- not on file
- Product code
- MID
- Firm FEI
- 3004973408
- Firm city
- Portage
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28