FDA Medical Device Recalls (openFDA)
Euro Diagnostica AB: Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.
- Recall number
- Z-2918-2018
- Recalling firm
- Euro Diagnostica AB
- Product
- Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.
- Status
- Terminated
- Initiated
- 2016-02-14
- Posted
- 2018-08-23
- Terminated
- 2019-11-05
- Reason
- Decreasing performance overtime.
- Root cause
- Nonconforming Material/Component
- Action
- None
- Quantity
- 25 kits (US only)
- Distribution
- Minnesota and Texas Foreign: Iran
- Lot, serial or model codes
- Lot # RS 3092, SS 1737
- 510(k) numbers
- ["K091657"]
- PMA numbers
- not on file
- Product code
- NHX
- Firm FEI
- 3007610287
- Firm city
- Malmo
- Firm state
- not on file
- Firm country
- Sweden
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