Bio-Rad Laboratories: 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.

Recall number

Z-2082-2011

Recalling firm

Bio-Rad Laboratories

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.

Status

Terminated

Initiated

2011-03-11

Posted

2011-04-27

Terminated

2011-12-22

Reason

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

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 BPD-ProductSupport@bio-rad.com for any questions

Quantity

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.

Lot, serial or model codes

Lot #46704.

510(k) numbers

["K062211"]

PMA numbers

not on file

Product code

LSE

Firm FEI

3008272466

Firm city

Redmond

Firm state

WA

Firm country

not on file

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

Copy