BioPlex 2200 12000670Recalls & reported problems
Bio-Rad Laboratories, Inc. · BioPlex 2200 ToRC IgM Reagent Pack · Class 2
All models of BioPlex 2200 (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Apr 14, 2022Class IIOpen, Classified
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
Z-1096-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII devices
- Atellica IM Toxo G 10995699Siemens Healthcare Diagnostics Inc. · ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII92 reports
- ADVIA Centaur® Toxo G 10310321Siemens Healthcare Diagnostics Inc. · ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII68 reports
- VIDAS® TOXOIgG AVIDITY 30222-01Biomerieux SA · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii1 recall0 reports
- IMMULITE® 2000 Systems TXP Toxoplasma Quantitatve IgG 10381323Siemens Healthcare Diagnostics Products Ltd · ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII49 reports
- Elecsys Toxo IgM 07028024190Roche Diagnostics GmbH · ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII42 reports
- Elecsys Toxo IgM 04618858190Roche Diagnostics GmbH · ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII29 reports
- Elecsys Toxo IgG 07028008190Roche Diagnostics GmbH · ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII22 reports
- ADVIA Centaur® Toxo M 10310320Siemens Healthcare Diagnostics Inc. · ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII8 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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