Z-2285-2012Class III

PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)

Name: Z-2285-2012 PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Creator: Phadia US Inc
Published: 2012-08-02
License: https://open.fda.gov/license/

Phadia AB / initiated 2012-08-02 / Terminated / root cause: labeling and UDI

FDA source

Phadia US Inc began a recall of PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies) on 2012-08-02. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2285-2012
Classification: Class III
Status: Terminated
Initiated: 2012-08-02
Posted: 2012-08-28
Terminated: 2012-12-12
Recalling firm: Phadia AB
Product: PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Product code: MID System, Test, Anticardiolipin Immunological
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 837 kits (96 assays per kit), total of 80,352 individual assays
Distribution: USA Nationwide.
Product codes and lots: Article Number 15696 Lot number #0067

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2285-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2285-2012	Class III	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-28

Product code MID

K020758Class IIVarelisa Cardiolipin Igm Antibodies, Models 15648 & 15696Pharmacia Deutschland GmbH / cleared 2002-05-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)