Z-2082-2011

BioPlex 2200 EBV IgG Calibrator Set. Catalog #663-1200. Product is labeled in part: "BIO-RAD***BioPlex 2200...

Name: Z-2082-2011 BioPlex 2200 EBV IgG Calibrator Set. Catalog #663-1200. Product is labeled in part: "BIO-RAD***BioPlex 2200...
Creator: Bio-Rad Laboratories
Published: 2011-03-11
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2011-03-11 / Terminated / root cause: manufacturing process

FDA source

Bio-Rad Laboratories began a recall of BioPlex 2200 EBV IgG Calibrator Set. Catalog #663-1200. Product is labeled in part: "BIO-RAD***BioPlex 2200 EBV IgG Calibrator Set***7 x 0.5 mL***A Calibrator... on 2011-03-11. The reason FDA records is "Bio-Rad Laboratories confirmed a downward shift in control values for EBV NA-1 analyte when using the BioPlex 2200 EBV IgG Calibrator Set Lot #46704". 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-2082-2011
Status: Terminated
Initiated: 2011-03-11
Posted: 2011-04-27
Terminated: 2011-12-22
Recalling firm: Bio-Rad Laboratories Inc.
Product: BioPlex 2200 EBV IgG Calibrator Set. Catalog #663-1200. Product is labeled in part: "BIO-RAD***BioPlex 2200 EBV IgG Calibrator Set***7 x 0.5 mL***A Calibrator set for the BioPlex 2200 EBV IgG Reagent Pack***UNITED STATES, Bio-Rad Laboratories, Inc., Hercules, CA 94547". BioPlex 2200 EBV IgG Calibrator Set is intended for the calibration of the BioPlex 2200 EBV IgG Reagent Pack.
Product code: LSE Epstein-Barr Virus, Other
Reason for recall: Bio-Rad Laboratories confirmed a downward shift in control values for EBV NA-1 analyte when using the BioPlex 2200 EBV IgG Calibrator Set Lot #46704.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The firm, Bio-Rad Laboratories, sent an "Voluntary Field Correction: BioPlex 2200 EBV IgG Calibrator Set, Lot# 46704 for EBV NA-1 Analyte" letter dated March 16, 2011 domestic customers via Fed-Ex and and to international subsidiaries via e-mail. The letter described the product, problem and actions to be taken. The consignees/customers were informed that Bio-Rad confirmed downward shift in control values for the EBV NA-1 analyte when using the BioPlex 2200 EBV IgG Calibrator Set, Lot # 46704. If this occurs, the customers were instructed to readjust the positive control mean using the procedure presented in the customer notification "BioPlex 2200 Quality Control Values (L60013402)". If the re-adjusted mean of the EBV NA-1 controls is within the manufacturer's limit, patient results may be reported. If the new assay positive control mean still does not fall within the manufacturer's limit, the customers were instructed to contact their local Bio-Rad Technical Support and do not report the EBV NA-1 values. The customers were also instructed to complete and return the CUSTOMER RESPONSE FORM via fax to 510-741-5775. If the BioPlex 2200 EBV VCA IgG and EBV EA-D IgG positive and negative control means are within the acceptable QC range, and subsequent passing QC runs are obtained, patient results may be reported for these analytes. Bio-Rad will be manufacturing a new lot of the BioPlex 2200 EBV IgG Calibrator Set which will bring the control values within the manufacturer's limit. It may be necessary to readjust the QC ranges after the consignees receive this new calibrator set lot. Bio-Rad will send their consignees/customers the replacement calibrators and calibrator CDs when available. The consignees/customers were also instructed to discard the calibrator set lot# 46704 in accordance with national and/or local regulations. Customers can call Clinical Diagnostics Group at 510-741-4431 or email to [email protected] for any questions
Quantity in commerce: 270 sets
Distribution: Worldwide distribution: USA including the following states: AL, AZ, CA, CT, FL, GA, HI, IL, IN, LA, MA, MD, MI, MN, NC, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and WI; and countries of: Australia, Czech Republic, France, Germany, Italy and Republic of Korea.
Product codes and lots: Lot #46704.

Product code LSE

K062211Class IBioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection SystemBio-Rad Laboratories, Inc. / cleared 2006-12-08

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)