Qualigen Inc Recalls
Showing 1-5 of 5 recalls
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 Di
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.
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.
Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
Specific lots have been reported to produce falsely lower than expected results for Vitamin D
The firm, Qualigen, sent an "URGENT: PRODUCT RECALL" letter dated 7/5/2017 to its customers by email or fax on 07/07/2017. The letter described the product, problem and actions to be taken. The customers were instructed to stop using the products immediately; discard any product remaining in your inventory; and complete, sign and return the attached CONFORMATION OF NOTIFICATION form by email to: babugan@qualigeninc.com or nsomera@qualigenic.com or fax to: 760-918-9127 by 7/15/2017. Please contact System Support at 877-709-2169, Option #2 if you need further assistance.
FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack Total PSA Immunoassay is designed for use with the FastPack System.
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Qualigen, Inc., notified customers of the recall by calling customers via telephone (with a telephone script) on 11/08/2013. The telephone (script) included the reason for recall, product description with codes, instructions and contact information. The customers were instructed to examine your inventory and discontinue use of the kits immediately. Qualigen will send you replacement kits and provide you with a shipping label to return all of the defective kits including any that were partially used. Feel free to contact System Support at 760.579.6900 if you have any questions or require assistance with returning your kits.
FastPack(R) Total PSA Immunoassay; Catalog #: 25000001 Is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack(R) Total PSA immunoassay is designed for use with the FastPack (R) System.
The recall was initiated after the firm investigation of customer complaints of falsely elevated results determined the product was not meeting product performance expectations.
The recall was initiated with Qualigen faxing a copy of the Product Notification letter, dated 9/29/2008, to all customers who have received any sublot of the affected product . Faxes were sent beginning 9/29/08. The recall letter informed the customers that the affected product was not meeting the firm's expectations for product performance. Customers were instructed to please stop using the affected lots immediately as they have been noted to produce falsely elevated results and they should confirm any result that appears to be inconsistent with "a patient's medical history, clinical examination, and other findings". In addition, they may wish to retest any patients that were run with a different FastPack lot. Beginning on 9/30/08, all customers were contacted by phone to confirm that they received the recall letter. The customers were shipped replacement products at no cost and as part of the product replacement process, they were instructed to return any unused Total PSA FastPacks/Kits of lot 0807002 to Qualigen.
Device to determine quantitative total testosterone in human serum
Kits may produce results that are falsely elevated.
All customers who received any one of the three lots have been faxed a removal letter starting 09/24/03. Certified or Airborne letter sent on 09/29/03.