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VITROS
ORTHO-CLINICAL DIAGNOSTICS, INC. · Model 6801734 · UDI-DI 10758750006830
CFN
Prescription
10
510(k) clearances
24
Adverse events
20
Recalls
19
Facilities
Description
VITROS Chemistry Products IgM Reagent
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-05-27 | Beckman Coulter Inc. | LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal |
| 2023-12-15 | Siemens Healthcare Diagnostics, Inc. | Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent. |
| 2023-07-12 | Beckman Coulter Inc. | Lipemic interference failed to meet the performance specification listed within the IFU. |
| 2022-08-30 | SIEMENS HEALTHCARE DIAGNOSTICS INC | N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF). |
| 2022-08-30 | SIEMENS HEALTHCARE DIAGNOSTICS INC | N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF). |
| 2019-07-29 | The Binding Site Group, Ltd. | There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. Thi |
| 2018-11-06 | The Binding Site Group, Ltd. | Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the sp |
| 2018-07-25 | The Binding Site Group, Ltd. | After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control results may be out of r |
| 2016-12-23 | The Binding Site Group, Ltd. | A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the |
| 2015-01-15 | Siemens Healthcare Diagnostics, Inc. | Complaints have been confirmed on failed proficiency testing due to serum samples recovering too low when using some N Latex IgM reagent kit lots 44018, 44019 and 44042. |
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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.