Phadia US Inc: Medical Device Recall in 2012 - (Recall #: Z-2285-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: August 2, 2012

Date Posted: September 5, 2012

Recall Number: Z-2285-2012

Event ID: 62572

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.

Status: Terminated

Product Quantity: 837 kits (96 assays per kit), total of 80,352 individual assays

Code Information:

Article Number 15696 Lot number #0067

Distribution Pattern:

USA Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated