FDA Medical Device Recalls (openFDA)
Bio-Rad Laboratories Inc: DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories.
- Recall number
- Z-1478-2011
- Recalling firm
- Bio-Rad Laboratories Inc
- Product
- DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories.
- Status
- Terminated
- Initiated
- 2010-03-01
- Posted
- 2011-03-02
- Terminated
- 2011-03-11
- Reason
- Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit.
- Root cause
- Nonconforming Material/Component
- Action
- Recall was initiated on 3/1/2010. DiaSorin S.R.I. (the sole consignee) was alerted via email using the firm's Medical Device Recall Notification. Consignee informed of the recall and instructed to dispose of the affected product according to local laws.
- Quantity
- 999 kits
- Distribution
- Foreign Only: One distributor, DiaSorin S.R.I. in Italy. No wholesalers. No retailers. No domestic distribution, No Federal Government sales/distribution centers.
- Lot, serial or model codes
- Model number N0093, manufacture dates 09/17/2009 and 10/12/2009, lot numbers 24592003and 24592035.
- 510(k) numbers
- ["K954723"]
- PMA numbers
- not on file
- Product code
- LKJ
- Firm FEI
- 2915274
- Firm city
- Hercules
- Firm state
- CA
- 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