FDA Medical Device Recalls (openFDA)
Qualigen Inc: FastPack(R) Total PSA Immunoassay; Catalog #: 25000001 Is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack(R) Total PSA immunoassay is designed for use with the FastPack (R) System.
- Recall number
- Z-0500-2009
- Recalling firm
- Qualigen Inc
- Product
- FastPack(R) Total PSA Immunoassay; Catalog #: 25000001 Is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack(R) Total PSA immunoassay is designed for use with the FastPack (R) System.
- Status
- Terminated
- Initiated
- 2008-09-29
- Posted
- 2008-12-22
- Terminated
- 2011-06-02
- Reason
- The recall was initiated after the firm investigation of customer complaints of falsely elevated results determined the product was not meeting product performance expectations.
- Root cause
- Other
- Action
- 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.
- Quantity
- 720 kits
- Distribution
- Worldwide Distribution --- including USA and countries of Canada, UK , Italy, Switzerland, Sweden, & South Korea.
- Lot, serial or model codes
- Lot Numbers: 0807002-901, 0807002-903, 0807002-904, 0807002-905, 0807002-906, 0807002-907, 0807002-908, and 0807002-909.
- 510(k) numbers
- ["K994419"]
- PMA numbers
- not on file
- Product code
- LTJ
- Firm FEI
- 3003355251
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28