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MONOLISA™
Bio-RAD Laboratories, Inc. · Model 26155 · UDI-DI 00847865002103
0
510(k) clearances
3,089
Adverse events (2 deaths)
33
Recalls
25
Facilities
Description
Anti-HBs EIA, Conjugate Diluent 15 mL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur |
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur |
| 2024-03-01 | Ortho-Clinical Diagnostics, Inc. | Potential for positively biased results due to signal reduction over shelf life. |
| 2023-11-27 | Ortho-Clinical Diagnostics, Inc. | Affected lots may experience increased calibration failures or an increase in falsely elevated results. |
| 2022-12-22 | Siemens Healthcare Diagnostics, Inc. | Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hepatitis B e Antigen (HBeAg) results on samples that are non-reactive wh |
| 2018-11-01 | ORTHO-CLINICAL DIAGNOSTICS | The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are |
| 2018-11-01 | ORTHO-CLINICAL DIAGNOSTICS | The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are |
| 2018-01-02 | Siemens Healthcare Diagnostics, Inc. | Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirol |
| 2018-01-02 | Siemens Healthcare Diagnostics, Inc. | Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirol |
| 2014-09-15 | Siemens Healthcare Diagnostics, Inc | Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results. |
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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.