Recall Z-0500-2009 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
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.
| Date | Dec 22, 2008 (initiated Sep 29, 2008) |
| Status | Terminated |
| 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 examina |
| Quantity | 720 kits |
| Distribution | Worldwide Distribution --- including USA and countries of Canada, UK , Italy, Switzerland, Sweden, & South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994419 | FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM Qualisys Diagnostics, Inc., Jun 28, 2000 |