Date Initiated by Firm | November 06, 2019 |
Create Date | April 06, 2020 |
Recall Status1 |
Terminated 3 on September 23, 2020 |
Recall Number | Z-1672-2020 |
Recall Event ID |
85134 |
510(K)Number | K182521 |
Product Classification |
Radioimmunoassay, testosterones and dihydrotestosterone - Product Code CDZ
|
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 |
Code Information |
1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P |
Recalling Firm/ Manufacturer |
Qualigen Inc 2042 Corte Del Nogal Carlsbad CA 92011-1438
|
For Additional Information Contact | Ben Abugan 760-918-9165 Ext. 237 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 systemsupport@qualigeninc.com. |
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. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = CDZ
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