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Terminated

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

FDA Recall Z-2285-2012 · Posted 2012-08-28

Recalling FirmPhadia US Inc
Recall StatusTerminated
Product CodeMID
Date Initiated2012-08-02
Date Terminated2012-12-12
Product Quantity837 kits (96 assays per kit), total of 80,352 individual assays

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.

Firm 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.

Root Cause

Labeling Change Control

Distribution Pattern

USA Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020758VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696Pharmacia Deutschland GmbH · 2002-05-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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