FDA Medical Device Recalls (openFDA)
Veridex, LLC: Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003
- Recall number
- Z-1472-2011
- Recalling firm
- Veridex, LLC
- Product
- Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003
- Status
- Terminated
- Initiated
- 2010-11-09
- Posted
- 2011-03-01
- Terminated
- 2014-03-28
- Reason
- There is a discrepancy between the assigned range of values on the high control label and the range listed on the Cell control Assigned Value Label for the Cell Search Circulating Tumor Cell Control Kit.
- Root cause
- Process control
- Action
- Veridex notified all affected consignees on November 11, 2010 by Federal Express overnight letter and prodivded with the informaiton regarding the label discrepancy. Foreign consignees were also notified on November 11, 2010 of the issue and instructed to notify their affected consignees. Consignees are asked to return the confirmation of receipt form by 11/29/2010.
- Quantity
- 122 US, 28 International
- Distribution
- Worldwide distribution, including: USA, Canada, France, UK, Germany, Italy, China, Spain & Portugal.
- Lot, serial or model codes
- Lot C512; Product code 7900003
- 510(k) numbers
- ["K040898"]
- PMA numbers
- not on file
- Product code
- NRS
- Firm FEI
- 3004619490
- Firm city
- Raritan
- Firm state
- NJ
- 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