FDA Medical Device Recalls (openFDA)
Euro Diagnostica AB: is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess of anti-cardiolipin IgG autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders
- Recall number
- Z-2920-2018
- Recalling firm
- Euro Diagnostica AB
- Product
- is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess of anti-cardiolipin IgG autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders
- 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
- 6
- Distribution
- MN
- Lot, serial or model codes
- Lot #'s: TS 2783 (kit) and TS 2787 (PC)
- 510(k) numbers
- ["K001574"]
- PMA numbers
- not on file
- Product code
- MID
- 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