FDA Medical Device Recalls (openFDA)
Diasorin Inc.: DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. Manufactured for DiaSorin Inc., 1951 Northwestern Avenue, Stillwater, MN 55082-0285
- Recall number
- Z-0632-05
- Recalling firm
- Diasorin Inc.
- Product
- DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. Manufactured for DiaSorin Inc., 1951 Northwestern Avenue, Stillwater, MN 55082-0285
- Status
- Terminated
- Initiated
- 2004-01-23
- Posted
- 2005-03-18
- Terminated
- 2006-07-22
- Reason
- DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.
- Root cause
- Other
- Action
- Customers were notified via a letter which described the product and the problem. Recommended to destroy all affected kits and stated that the kits will be replaced.
- Quantity
- 16 kits
- Distribution
- GA, NY & KS
- Lot, serial or model codes
- catalog # 7800, lot # 039229, expiration date 12/23/04
- 510(k) numbers
- ["K001981"]
- PMA numbers
- not on file
- Product code
- MID
- Firm FEI
- 2182595
- Firm city
- Stillwater
- Firm state
- MN
- Firm country
- not on file
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