CLASS II Device recall · Reported 25 Dec 2013 · FDA Enforcement Report
FastPack Free T4 Immunoassay Chemilunescence assay recalled by Qualigen
Qualigen is recalling FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 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
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-0549-2014
- 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 Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for use with the FastPack System.
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.
AlabamaCaliforniaIndianaKansasKentuckyMassachusettsNorth CarolinaNevadaNew YorkOklahomaSouth CarolinaTennesseeTexasUtahVirginiaWashington
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 25000043. Lot Number 1310028-2P.Exp Date: 4/10/2014
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 66842This product is part of a recall event; the main page for the event is FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay recalled | Qualigen | Device Malfunction | 16 states | |
| CLASS II | FastPack Testosterone Immunoassay Chemilunescence assay recalled | Qualigen | Device Malfunction | 16 states | |
| CLASS II | FastPack Total PSA Immunoassay Chemilunescence assay recalled | Qualigen | Device Malfunction | 16 states |
More recalls from Qualigen
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | The FastPack IP Sex Hormone Binding Globulin Immunoassay recalled | Qualigen | Potency & Assay | 15 states |
| Device | CLASS II | FastPack TSH Calibrator Kit recalled by Qualigen | Qualigen | Potency & Assay | 25 states |
| Device | CLASS II | The FastPack System Comlete Immunoassay Kit Immunoassay recalled | Qualigen | Labeling Errors | Nationwide |
| Device | CLASS II | Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit recalled | Qualigen | Potency & Assay | Nationwide |
| Device | CLASS II | FastPack Total PSA Immunoassay Chemilunescence assay recalled | Qualigen | Device Malfunction | 16 states |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |