Recall Z-0547-2014 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Qualigen Inc
FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay 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 Total PSA Immunoassay is designed for use with the FastPack
| Date | Dec 19, 2013 (initiated Nov 8, 2013) |
| Status | Terminated |
| Reason | Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. |
| Root cause | Process change control |
| Action | Qualigen, Inc., notified customers of the recall by calling customers via telephone (with a telephone script) on 11/08/2013. The telephone (script) included the reason for recall, product description with codes, instructions and contact information. The customers were instructed to examine your inventory and discontinue use of the kits immediately. Qualigen will send you replacement kits and provide you with a shipping label to return all of the defective kits including any that were partially used. Feel free to contact System Support at 760.579.6900 if you have any questions or require assi |
| Quantity | 182 |
| Distribution | US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA. |
| 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 |