FDA Medical Device Recalls (openFDA)
Vital Scientific N.V.: Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
- Recall number
- Z-0157-2020
- Recalling firm
- Vital Scientific N.V.
- Product
- Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
- 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
- 5 instruments
- Distribution
- US Nationwide in the states of NY, and UT
- Lot, serial or model codes
- serial numbers: 11-7425; 11-7516; 11-7535; 11-7563; 11-7564.
- 510(k) numbers
- ["K102647"]
- PMA numbers
- not on file
- Product code
- JGS
- 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