FDA Medical Device Recalls (openFDA)
Qualigen Inc: FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo Immunoassay is designed for use with the FastPack System.
- Recall number
- Z-0548-2014
- Recalling firm
- Qualigen Inc
- Product
- FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo Immunoassay is designed for use with the FastPack System.
- Status
- Terminated
- Initiated
- 2013-11-08
- Posted
- 2013-12-19
- Terminated
- 2014-09-18
- 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 assistance with returning your kits.
- Quantity
- 18
- Distribution
- US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
- Lot, serial or model codes
- Testosterone. Catalog Number 25000041. Lot Number 1310019-3P Exp Date: 9/22/2014
- 510(k) numbers
- ["K021972"]
- PMA numbers
- not on file
- Product code
- CDZ
- Firm FEI
- 3003355251
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28