FDA Medical Device Recalls (openFDA)
Bio-Rad Laboratories: BIO-RAD BioPlex 2200 Syphilis IgG Control Set. Lot # 46636 The BioPlex 2200 Syphilis IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Syphilis IgG Reagent Pack in the clinical laboratory.
- Recall number
- Z-1650-2011
- Recalling firm
- Bio-Rad Laboratories
- Product
- BIO-RAD BioPlex 2200 Syphilis IgG Control Set. Lot # 46636 The BioPlex 2200 Syphilis IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Syphilis IgG Reagent Pack in the clinical laboratory.
- Status
- Terminated
- Initiated
- 2010-11-23
- Posted
- not on file
- Terminated
- 2011-08-04
- Reason
- An upward shift in the control values can result in a control value that falls outside of the current manufacturing ranges.
- Root cause
- Other
- Action
- The firm, Bio-Rad, sent a "Voluntary Field Correction: QC Ranges for Syphilis IgG Control Set Lot#46636" letter to Domestic customers via FedEx on November 24, 2010 and to the International customers via e-mail on November 23, 2010. The letter described the product, problem and actions to be taken by customers. The Customers were advised to temporarily establish their own means and acceptable ranges for Control Lot 46636 for the r15 and r47 markers. The firm will provide adjusted recommended means and acceptable ranges. Additionally, the customers were to complete and return the Customer Response Form for USA and/or the Subsidiary Response Form (Outside US) via fax to (510) 741-4846, Attn: Bio-Rad BPD-Product Support. If you have any questions about this notification, contact your local Bio-Rad Technical Support.
- Quantity
- 202
- Distribution
- Worldwide distribution: USA and countries including: Canada, Czech Republic, France, Germany, and Italy.
- Lot, serial or model codes
- Catalog #: 663-1430 Lot #: 46636
- 510(k) numbers
- K063866
- PMA numbers
- not on file
- Product code
- LIP
- Firm FEI
- 3008272466
- Firm city
- Redmond
- Firm state
- WA
- 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