Recall Z-2285-2012— Phadia US Inc

Name: FDA recall Z-2285-2012
Creator: U.S. Food and Drug Administration
Published: 2012-08-02

Class III · Terminated

Class III FDA medical device recall by Phadia US Inc, initiated 2012-08-02, terminated 2012-12-12. It names one FDA 510(k) clearance: K020758. 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..

Recalling firm: Phadia US Inc
Classification: Class III
Status: Terminated
Initiated: 2012-08-02
Terminated: 2012-12-12
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K020758 — VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696Pharmacia Deutschland GmbH·cleared 2002-05-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.