Reported Oct 16, 2024 · Ongoing
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Luminex Molecular Diagnostics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Luminex Molecular Diagnostics Inc · 439 University Ave Suite 900 · Toronto · N/A
Is this the product you have?
- NxTAG Respiratory Pathogen Panel +SARS-CoV-2
- REFI056C0468
- Lot codes and dates
- Lot/Expiration
IK056C-0033/ 9/30/2024IK056C-0034/ 10/31/2024IK056C-0035/ 10/31/2024IK056C-0036/ 12/31/2024IK056C-0037/ 12/31/2024IK056C-0038/ 12/31/2024IK056C-0039/ 1/31/2025
- Lot/Expiration
- Amount recalled
- 613
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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