FDA Medical Device Recalls (openFDA)
Bio-Rad Labroatories Inc.: BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains the Syphilis IgG Assay Protocol File LAPF CD
- Recall number
- Z-0256-2008
- Recalling firm
- Bio-Rad Labroatories Inc.
- Product
- BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains the Syphilis IgG Assay Protocol File LAPF CD
- Status
- Terminated
- Initiated
- 2007-09-25
- Posted
- 2007-11-09
- Terminated
- 2008-04-16
- Reason
- Mislabeling: Reporting terminology in the Syphilis IgG APF CD is not consistent with the distributed Instructions for Use. (Non-Reactive and Reactive rather than Negative and Positive)
- Root cause
- Labeling Change Control
- Action
- The recalling firm notified consignees by phone call on 9/25/2007, followed up with a fax notification. The firm plans to monitor the consignees that do not respond by tracking on a spreadsheet and following up with another phone call. Consignees are instructed to destroy the APF CD which will be replaced at a later date.
- Quantity
- 36
- Distribution
- Nationwide
- Lot, serial or model codes
- Cat. No. 665-1460A containing APF CD SW2_v1.
- 510(k) numbers
- ["K063866"]
- PMA numbers
- not on file
- Product code
- LIP
- 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