SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM HBC TOTAL 2 (HBCT2); TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
|
Back to Search Results |
|
Model Number N/A |
Device Problem
False Negative Result (1225)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/14/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
A customer from outside the united states reported observation of nonreactive (negative) atellica im hbc total 2 (hbct2) results which were discordant relative to clinical expectation and alternate-method testing.No issues were identified with assay calibration or quality control (qc), and no problems have been seen with other assays.The assay's instructions for use (ifu) states the following, under limitations: "the performance of the assay has not been established for populations of immunocompromised or immunosuppressed patients." "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay is designed to minimize interference from heterophilic antibodies.Additional information may be required for diagnosis." siemens is investigating.
|
|
Event Description
|
The customer reports observation of nonreactive (negative) atellica im hbc total 2 (hbct2) results which were discordant relative to clinical expectation and alternate-method testing.Hbct2 kit lot 008 was in use at the time.Initial nonreactive hbct2 results for the affected patients were questioned by laboratory clinicians, and not reported.The laboratory sent the samples for repeat testing at another laboratory, using a different assay method.Conflicting positive results were produced by the alternate method and were accepted as the correct results.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed result discordance.
|
|
Search Alerts/Recalls
|
|
|