Z-1650-2011

BIO-RAD BioPlex 2200 Syphilis IgG Control Set. Lot # 46636 The BioPlex 2200 Syphilis IgG Control Set is...

Name: Z-1650-2011 BIO-RAD BioPlex 2200 Syphilis IgG Control Set. Lot # 46636 The BioPlex 2200 Syphilis IgG Control Set is...
Creator: Bio-Rad Laboratories
Published: 2010-11-23
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2010-11-23 / Terminated / root cause: manufacturing process

FDA source

Bio-Rad Laboratories began a recall of 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... on 2010-11-23. The reason FDA records is "An upward shift in the control values can result in a control value that falls outside of the current manufacturing ranges". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1650-2011
Status: Terminated
Initiated: 2010-11-23
Posted: 2015-06-26
Terminated: 2011-08-04
Recalling firm: Bio-Rad Laboratories Inc.
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.
Product code: LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Reason for recall: An upward shift in the control values can result in a control value that falls outside of the current manufacturing ranges.
Root cause tag: manufacturing process
FDA 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 in commerce: 202
Distribution: Worldwide distribution: USA and countries including: Canada, Czech Republic, France, Germany, and Italy.
Product codes and lots: Catalog #: 663-1430 Lot #: 46636

Product code LIP

K063866Class IIBioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte Detection SystemBio-Rad Laboratories / cleared 2007-03-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)