FDA Medical Device Recalls (openFDA)
Vital Scientific N.V.: V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
- Recall number
- Z-0156-2020
- Recalling firm
- Vital Scientific N.V.
- Product
- V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
- Status
- Terminated
- Initiated
- 2012-01-10
- Posted
- not on file
- Terminated
- 2024-04-19
- Reason
- The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
- Root cause
- Component design/selection
- Action
- The firm reached out to consignees via phone to inform them of the affected product.
- Quantity
- 39 instruments
- Distribution
- US Nationwide in the states of NY, and UT
- Lot, serial or model codes
- serial numbers: 10-3331; 10-3332; 11-3301; 11-3304 through 11-3306; 11-3308 through 11-3312; 11-3315; 11-3316; 11-3318 through 11-3342; 12-3302.
- 510(k) numbers
- ["K973628"]
- PMA numbers
- not on file
- Product code
- JJF
- Firm FEI
- 2708
- Firm city
- Dieren
- Firm state
- not on file
- Firm country
- Netherlands
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