FDA Medical Device Recalls (openFDA)
Bio-Rad Laboratories Inc: Autoimmune EIA ANA Screening Test Kit, 576 Tests, Model/Catalog Number: 576AN manufactured by Bio-Rad, Hercules, CA.
- Recall number
- Z-0540-2011
- Recalling firm
- Bio-Rad Laboratories Inc
- Product
- Autoimmune EIA ANA Screening Test Kit, 576 Tests, Model/Catalog Number: 576AN manufactured by Bio-Rad, Hercules, CA.
- Status
- Terminated
- Initiated
- 2010-03-01
- Posted
- 2010-12-06
- Terminated
- 2011-01-05
- Reason
- The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading.
- Root cause
- Other
- Action
- Bio-Rad issued an Urgent Medical Device Recall Notification letter dated March 1, 2010 to customers describing the issue and actions to be taken. Responses will be tracked via response forms. The letter instructed customers that affected products should be identified, quarantined, and discarded, or reworked with shorter expiration dates until newer lots are available. Bio-Rad can be contacted at 510-724-7000 concerning this recall.
- Quantity
- not on file
- Distribution
- Worldwide Distribution: Throughout the US, and to the countries of: Australia, Canada, France, Hong Kong, India, Italy, Japan, New Zealand, Panama, Singapore, South Korea and the UK.
- Lot, serial or model codes
- Lot Numbers: 24591525, 24591572, 24592100, 24592396, 24500034
- 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