Catalog Number 09211101190 |
Device Problems
False Positive Result (1227); Output Problem (3005); Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/27/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation is ongoing.Reagent lot 21114z expiration date: 30-apr-2024.Reagent lot 30109f expiration date: 30-jun-2024.
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Event Description
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In light of the covid-19 pandemic and the subsequent emergency use authorizations (euas) for sars-cov-2 diagnostic tests, the agency has requested heightened reporting beyond the reasonably suggests requirements of 803 to include allegations of false positive or false negative results independent of harm or malfunction or off-label use.Pursuant to the agency¿s instruction, we hereby submit this mdr.A customer alleged discrepant results for an eqa sample while using the cobas® sars-cov-2 & influenza a/b nucleic acid test on the cobas® liat® system.The alleged sample is an external quality assessment (eqa) sample expected to be negative for influenza b.The sample was tested twice on two different cobas liat analyzers generating a positive result for influenza b.No harm was alleged.An investigation is being conducted to evaluate the customer issue.Per fda¿s eua guidance, 1 mdr will be filed.
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Manufacturer Narrative
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The observed discrepancy could be due to the sample being a weak positive near the beginning of infection for the flu b target that is at/near the limit of detection (lod) of the assay and/or a low-level contamination due to handling.
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Search Alerts/Recalls
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