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BioPlex 2200
BIO-RAD LABORATORIES, INC. · Model SW 4_2 · UDI-DI 00847865002189
8
510(k) clearances
7
Adverse events
7
Recalls
21
Facilities
Description
U.S. IFU, Manual & CDs, BioPlex 2200, MMRV IgG IFU, SW4_v2
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed result |
| 2018-01-05 | Diamedix Corporation | Contains a gel-like contaminant that may affect product performance. |
| 2014-10-20 | Diamedix Corporation | A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. |
| 2013-01-23 | Bion Enterprises Ltd | Affected products have a labeled expiration date of one year too long. |
| 2012-03-08 | Zeus Scientific, Inc. | Select lots of AtheNA Multi-Lyte MMV Test System have lost reactivity and may produce false positive results in seronegative patients who have not been previously affected with or |
| 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, |
| 2005-08-08 | Diasorin Inc. | Potential for false negative results. A software anomaly may occur when performing the ETI-Mumps IgG assay on the ETI-Max 3000 automated platform. The error occurs when running a |
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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.