FDA Medical Device Recalls (openFDA)
Euro Diagnostica AB: is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.
- Recall number
- Z-2922-2018
- Recalling firm
- Euro Diagnostica AB
- Product
- is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.
- Status
- Terminated
- Initiated
- 2016-10-21
- Posted
- 2018-08-23
- Terminated
- 2019-11-05
- Reason
- Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
- Root cause
- Error in labeling
- Action
- none
- Quantity
- 4
- Distribution
- MN
- Lot, serial or model codes
- Lot #'s: TS 1740 (kit) and TS 1743 (PC)
- 510(k) numbers
- ["K912291"]
- PMA numbers
- not on file
- Product code
- LKJ
- 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