FastPack Total PSA Immunoassay Chemilunescence assay for the… — Class II medical device recall Z-0547-2014
Terminated recall by Qualigen Inc, reported 2013-12-25, distributed in AL, CA, IN, KS, KY, MA, NC, NV…. Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufac
| Recall number | Z-0547-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qualigen Inc, Carlsbad, CA, United States |
| Recall initiated | 2013-11-08 |
| Classified | 2013-12-19 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2014-09-18 |
| Distributed | AL, CA, IN, KS, KY, MA, NC, NV, NY, OK, SC, TN, TX, UT, VA, WA |
| Quantity | 182 |
| Lot numbers | 1309038-10P |
| Model numbers | 25000040 |
| Expiration dates | 2013-06-26 |
Product
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 System.
Reason for recall
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0547-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.