FDA Medical Device Recalls (openFDA)
Bio-Rad Laboratories Inc: Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by Bio-Rad Laboratories, Inc.
- Recall number
- Z-0612-2011
- Recalling firm
- Bio-Rad Laboratories Inc
- Product
- Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by Bio-Rad Laboratories, Inc.
- Status
- Terminated
- Initiated
- 2010-06-24
- Posted
- 2010-12-13
- Terminated
- 2011-08-08
- Reason
- Product mislabeled-- the ANA cutoff Control and Prostiva controls were mislabeled. Use of the incorrect controls will cause run failure - patient results cannot be reported because controls will not pass..
- Root cause
- Labeling mix-ups
- Action
- Bio-Rad issued Medical Device Recall Notification letters dated June 24, 2010 to consignees, identifying the affected products and requested that all affected product be disposed of in accordance with local procedures. Response forms are to be completed and returned to the firm. Bio-Rad can be contacted for replacement product and about this recall at 510 741-6114.
- Quantity
- 37 units
- Distribution
- Nationwide Distribution: including the states of California, Ohio, Massachusetts, and Missouri. Product delivered to 11 consignees only in the US.
- Lot, serial or model codes
- Manufactured on 06/07/2010, lot number 24501097
- 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