Z-0805-2025Class III

The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement...

Name: Z-0805-2025 The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement...
Creator: Qualigen Inc
Published: 2024-12-03
License: https://open.fda.gov/license/

Qualigen Inc / initiated 2024-12-03 / Open, Classified / root cause: labeling and UDI

FDA source

Qualigen Inc began a recall of 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... on 2024-12-03. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0805-2025
Classification: Class III
Status: Open, Classified
Initiated: 2024-12-03
Posted: 2025-01-03
Recalling firm: Qualigen Inc
Product: 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.
Product code: CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: The recalling firm issued letters dated 11/19/2024 via email to their customers explaining the reason for recall and providing the correct expiration dates for each of the affected lot numbers. The risk to health was provided and instructions given to be completed. The instructions were to cease use of the affected product, dispose of all remaining kits from the affected lot numbers, document the number of kits disposed, complete the acknowledgment form by FAX or email within 5 days.
Quantity in commerce: 426
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.
Product codes and lots: UDI-DI: 20816467020345, Lot numbers: 2408018-1 Exp: 2025-09-05; 2409015-1, Exp: 2025-06-27; and 2409015-2, Exp: 2025-06-26.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0805-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0805-2025	Class III	Ongoing	Voluntary: Firm initiated	2025-01-15	2025-01-03

Product code CDZ

K182521Class IFastPack IP Sex Hormone Binding Globulin ImmunoassayQualigen, Inc. / cleared 2019-01-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)