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BioPlex 2200
BIO-RAD LABORATORIES, INC. · Model SW4_V2 · UDI-DI 00847865002127
10
510(k) clearances
4
Adverse events
7
Recalls
15
Facilities
Description
Manual & CDs, BioPlex 2200, EBV IgG IFU, SW4_v2
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2014-10-20 | Diamedix Corporation | A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. |
| 2011-03-11 | Bio-Rad Laboratories | 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. |
| 2008-08-27 | Calbiotech Inc | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, |
| 2007-11-13 | Bio-Rad Laboratories | False negative results due to reagent packs exhibiting low signal. |
| 2007-11-13 | Bio-Rad Laboratories | False negative results due to reagent packs exhibiting low signal. |
| 2004-11-01 | Diasorin Inc. | The DiaSorin ETI-EA-G kits contained the wrong microtiter plate. The plate provided in the kits was for a different product, the ProTrac II Tacrolimus kit. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.