CLASS II Device recall · Reported 25 Dec 2013 · FDA Enforcement Report

FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay recalled

Qualigen is recalling FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the, distributed in 16 states. The recall was initiated on 8 Nov 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesTestosterone. Catalog Number 25000059. Lot Number 1309062-2P.Exp Date: 7/9/2014

Quantity recalled6

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0550-2014
FDA event ID: 66842
Recalling firm: Qualigen, Carlsbad, CA
Classification: Class II
Status: Terminated
Recall initiated: 8 Nov 2013
FDA classified: 19 Dec 2013
Reported: 25 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

8 Nov 2013	Recall initiated by company
19 Dec 2013	Classified by FDA	+41 days
25 Dec 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack Vitamin D Immunoassay is intended for the quantitative determination of 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.

Where it was distributed

US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.

Alabama California Indiana Kansas Kentucky Massachusetts North Carolina Nevada New York Oklahoma South Carolina Tennessee Texas Utah Virginia Washington

Questions about this recall

Why was it recalled?

Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.

Which lots are affected?

Testosterone. Catalog Number 25000059. Lot Number 1309062-2P.Exp Date: 7/9/2014

Where was it sold?

US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 66842

Reported	Class	Recall	Company	Reason	Where
25 Dec 2013	CLASS II	FastPack Testosterone Immunoassay Chemilunescence assay recalled	Qualigen	Device Malfunction	16 states
25 Dec 2013	CLASS II	FastPack Total PSA Immunoassay Chemilunescence assay recalled	Qualigen	Device Malfunction	16 states
25 Dec 2013	CLASS II	FastPack Free T4 Immunoassay Chemilunescence assay recalled by Qualigen	Qualigen	Device Malfunction	16 states

More recalls from Qualigen

All 8

Reported	Class	Recall	Company	Reason	Where
15 Jan 2025Device	CLASS III	The FastPack IP Sex Hormone Binding Globulin Immunoassay recalled	Qualigen	Potency & Assay	15 states
16 Oct 2024Device	CLASS II	FastPack TSH Calibrator Kit recalled by Qualigen	Qualigen	Potency & Assay	25 states
15 Apr 2020Device	CLASS II	The FastPack System Comlete Immunoassay Kit Immunoassay recalled	Qualigen	Labeling Errors	Nationwide
13 Sep 2017Device	CLASS II	Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit recalled	Qualigen	Potency & Assay	Nationwide
25 Dec 2013Device	CLASS II	FastPack Free T4 Immunoassay Chemilunescence assay recalled by Qualigen	Qualigen	Device Malfunction	16 states

Other Test Kits & Diagnostics recalls

All 2,668

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	MAS Omni Immune PRO Liquid Assayed Integrated Immunoassay recalled	Microgenics	Potency & Assay	Nationwide
21 Oct 2026Device	CLASS II	The ABL90 Flex and ABL90 Flex Plus analyzers are intended recalled	Radiometer Medical ApS	Labeling Errors	Nationwide
21 Oct 2026Device	CLASS I	HemoslL AcuStar HIT-lgG(PF-4) recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
21 Oct 2026Device	CLASS III	LeadCare II Blood Lead Test Kit recalled by Magellan Diagnostics	Magellan Diagnostics	Other	Nationwide
21 Oct 2026Device	CLASS I	HemoslL AcuStar HIT-lgG(PF-4) recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide