Z-0547-2014Class II

FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA...

Name: Z-0547-2014 FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA...
Creator: Qualigen Inc
Published: 2013-11-08
License: https://open.fda.gov/license/

Qualigen Inc / initiated 2013-11-08 / Terminated / root cause: manufacturing process

FDA source

Qualigen Inc began a recall of FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay... on 2013-11-08. FDA classified it as Class II and gives the reason as "Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0547-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-08
Posted: 2013-12-19
Terminated: 2014-09-18
Recalling firm: Qualigen Inc
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.
Product code: LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Reason for recall: Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Root cause tag: manufacturing process
FDA 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 assistance with returning your kits.
Quantity in commerce: 182
Distribution: US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
Product codes and lots: Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0547-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0547-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-19
Z-0548-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-19
Z-0549-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-19
Z-0550-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-19

Product code LTJ

K994419Class IIFastpack Psa Immunoassay, Fastpack SystemQualisys Diagnostics, Inc. / cleared 2000-06-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)