Recall Z-3112-2017 ยท MRG System, Test, Vitamin D
Qualigen Inc
Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
| Date | Jul 7, 2017 |
| Status | Terminated |
| Reason | Specific lots have been reported to produce falsely lower than expected results for Vitamin D |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 493 units |
| Distribution | Worldwide Distribution: US (Nationwide) and to countries of: Germany, Switzerland, turkey and UAE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123983 | FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS Qualigen, Inc., Jul 3, 2013 |