Facility

QUALIGEN, INC.

5 recall(s) on record — most severe on record: Class II.

Key facts

5recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3003355251
Establishment type	Manufacture Medical Device
Location	2042 CORTE DEL NOGAL CARLSBAD, CA, US 92011
Registration status	Active · expires 2026
Parent company	QUALIGEN, INC. (owner-operator 9040045)
Brand names	FastPack PSA Controls

Activity by year

Recalls (5)

Devices registered here (1)

Single (Specified) Analyte Controls (Assayed And Unassayed)
Product code JJX (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1660

Recalls & enforcement

Class IIIOngoing2024-12-03
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 Q…
Class IIOngoing2024-08-26
Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher than expected.
Class IITerminated2019-11-06
The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasma.
Class IITerminated2017-07-07
Specific lots have been reported to produce falsely lower than expected results for Vitamin D
Class IITerminated2013-11-08
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.

All facilities operated by QUALIGEN, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “QUALIGEN, INC. (FEI 3003355251) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003355251-qualigen-inc/

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