Qualigen Inc: Device Recall
Recall #Z-0805-2025 · 12/03/2024
Class III: Low Risk
Recall Details
- Recall Number
- Z-0805-2025
- Classification
- Class III
- Product Type
- Device
- Recalling Firm
- Qualigen Inc
- Status
- Ongoing
- Date Initiated
- 12/03/2024
- Location
- Carlsbad, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 426
Reason for Recall
Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, and 2409015-2. The likelihood of patient harm is expected to be low as routine Quality Control should detect kits that are impacted by signal deterioration due to age.
Product Description
The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.
Distribution Pattern
Distribution was made to AR, CA, CO, FL, IL, IN, MA, MO, NC, NY, OH, OK, TN, TX, and VA. There was no military/government/foreign distribution.
Other Recalls by Qualigen Inc
- Class II: Risk 08/26/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.