Bio-Rad Laboratories, Inc. 25178Recalls & reported problems
Bio-RAD Laboratories, Inc. · CMV IgM EIA · Class 2
Data updated Oct 16, 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.
1 other recall cover devices cleared under the same FDA submission (K982485); they may or may not involve this specific model.
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 16, 2026.
Recalls naming this device
- Oct 19, 2022Open, Classified
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
Z-0342-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K982485. One submission often covers many models, so check the product and lot details in each record.
- Z-0837-2012 · Sep 28, 2010 · TerminatedSeraQuest***CMV IgM TEST SET For the detection of CMV IgM Antibodies 96 Test Set Cat. No. 01-150 Store 2-8 C For In Vitro Diagnostic Use***Contents: 1 96 wells bag with holder, 1
Other ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS devices
- Elecsys CMV IgG 09118551190Roche Diagnostics GmbH · ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS43 reports
- Elecsys CMV IgM 07027133190Roche Diagnostics GmbH · ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS22 reports
- Elecsys CMV IgG 07027117190Roche Diagnostics GmbH · ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS8 reports
- IMMULITE® 2000 Systems CVG CMV IgG 10381309Siemens Healthcare Diagnostics Products Ltd · ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS6 reports
- VIDAS® CMV IgG 30204-01Biomerieux SA · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus3 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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