FDA Medical Device Recalls (openFDA)
Qualigen Inc: Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
- Recall number
- Z-3112-2017
- Recalling firm
- Qualigen Inc
- Product
- Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
- Status
- Terminated
- Initiated
- 2017-07-07
- Posted
- not on file
- Terminated
- 2018-10-22
- 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.
- Lot, serial or model codes
- Lot numbers: 1701033-3P, 1701033-4P, 1701033-5P, and 1701033-6P
- 510(k) numbers
- ["K123983"]
- PMA numbers
- not on file
- Product code
- MRG
- Firm FEI
- 3003355251
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28