The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in
Summary
The FDA issued a Class III for The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for by Qualigen Inc. Reason: 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.
Details
Source
Device Recall
External ID
Z-0805-2025
Action Date
2025-01-15
Status
Ongoing
Category
device
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.
Lot/Code Info: UDI-DI: 20816467020345, Lot numbers: 2408018-1 Exp: 2025-09-05; 2409015-1, Exp: 2025-06-27; and 2409015-2, Exp: 2025-06-26.
Quantity Affected: 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.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-03
Company
Carlsbad, CA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Qualigen Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Qualigen Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Qualigen Inc have FDA actions?
Qualigen Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0805-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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