Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 15, 2020
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
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Qualigen Inc recalled The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measureme… - a moderate-severity action.
The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measureme… was recalled by Qualigen Inc in April 15, 2020. Reason: The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inac…. Check the official notice for the remedy. Verify recall #Z-1672-2020 with the FDA Devices before acting.
The recall
Qualigen Inc issued this moderate-severity FDA Devices recall-The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inac….
- Moderate
- severity level
- Class II
- classification
- April 15, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1672-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1672-2020) was formally reported on April 15, 2020, with the manufacturer initiating the action on November 6, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Qualigen Inc is listed as the recalling firm, operating out of Carlsbad, CA. Federal records list the affected scope as 24 Kits (30 test packs each) 720 tests.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of AL, AK, CA, HI, and TX.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
24 Kits (30 test packs each) 720 tests
Related Recalls
6
3 from same agency
Product description
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1672-2020 |
| Date reported | April 15, 2020 |
| Date initiated | November 6, 2019 |
| Recalling firm | Qualigen Inc |
| Firm location | Carlsbad, CA |
| Affected scope | 24 Kits (30 test packs each) 720 tests |
| Distribution | US Nationwide distribution in the states of AL, AK, CA, HI, and TX. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1672-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Qualigen Inc. Units affected: 24 Kits (30 test packs each) 720 tests.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 15, 2020. Severity: Moderate. Recall number: Z-1672-2020.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of AL, AK, CA, HI, and TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1672-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 15, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.