Z-1672-2020Class II

The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a...

Name: Z-1672-2020 The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a...
Creator: Qualigen Inc
Published: 2019-11-06
License: https://open.fda.gov/license/

Qualigen Inc / initiated 2019-11-06 / Terminated / root cause: manufacturing process

FDA source

Qualigen Inc began a recall of The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the... on 2019-11-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1672-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-06
Posted: 2020-04-06
Terminated: 2020-09-23
Recalling firm: Qualigen Inc
Product: The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. Each Kit Contains 30 FastPack IP SHBG Immunoassays 1 Calibrator 1 x 3 mL Vial 1 Control 1 1 x 3 mL Vial 1 Control 2 1 x 3 mL Vials 32 Sample Diluent 0.9 mL Vials REF 25000081 IVD CE 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P
Product code: CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On October 31, 2019, a "Urgent: Product Recall" letter was sent to customer via E-Mail. In addition to informing consignees about the recall the customer notification asked consignees to take the following actions: 1. The firm will provide replacement kits at no cost as soon as they become available. 2. For any kits that have been purchased a refund can be requested in place of replacement kits. 3. As part of the product replacement process, please confirm that any remaining SHBG FastPacks/Kits of Lot Number 1908038-1P have been discarded on the form below. 4. The firm will call to confirm that you have received the letter and provide any additional details you may require. For questions, please contact System Support at [email protected].
Quantity in commerce: 24 Kits (30 test packs each) 720 tests
Distribution: US Nationwide distribution in the states of AL, AK, CA, HI, and TX.
Product codes and lots: 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1672-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1672-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-06

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)