Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
FDA Recall Z-3112-2017 · Posted None
Advertisement
Recalling FirmQualigen Inc
Recall StatusTerminated
Product CodeMRG
Date Initiated2017-07-07
Date Terminated2018-10-22
Product Quantity493 units
Reason for Recall
Specific lots have been reported to produce falsely lower than expected results for Vitamin D
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: [email protected] or [email protected] 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.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution: US (Nationwide) and to countries of: Germany, Switzerland, turkey and UAE.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement