FastPack(R) Total PSA Immunoassay; Catalog #: 25000001 Is a paramagnetic particle immunoassay for the in vitro quantitat

FDA device recall Z-0500-2009 · posted 2008-12-22 · Terminated

Recall details

Recalling firm

Qualigen Inc

Reason for recall

The recall was initiated after the firm investigation of customer complaints of falsely elevated results determined the product was not meeting product performance expectations.

Action taken

The recall was initiated with Qualigen faxing a copy of the Product Notification letter, dated 9/29/2008, to all customers who have received any sublot of the affected product . Faxes were sent beginning 9/29/08. The recall letter informed the customers that the affected product was not meeting the firm's expectations for product performance. Customers were instructed to please stop using the affected lots immediately as they have been noted to produce falsely elevated results and they should confirm any result that appears to be inconsistent with "a patient's medical history, clinical examination, and other findings". In addition, they may wish to retest any patients that were run with a different FastPack lot. Beginning on 9/30/08, all customers were contacted by phone to confirm that they received the recall letter. The customers were shipped replacement products at no cost and as part of the product replacement process, they were instructed to return any unused Total PSA FastPacks/Kits of lot 0807002 to Qualigen.

Root cause

Other

Status

Terminated

Product code

LTJ

Quantity affected

720 kits

Distribution

Worldwide Distribution --- including USA and countries of Canada, UK , Italy, Switzerland, Sweden, & South Korea.

Date initiated

2008-09-29

Date posted

2008-12-22

Date terminated

2011-06-02

Location

Carlsbad, CA

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