Reported Oct 16, 2024 · Ongoing
NxTAG Respiratory Pathogen Panel, REF: I051C0447
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
- REFI051C0447
- Lot codes and dates
- UDI-DI00840487100417
- Lot/Expiration
IK051C-0181/ 9/30/2024IK051C-0182/ 9/30/2024IK051C-0185/ 9/30/2024IK051C-0186/ 9/30/2024IK051C-0187/ 10/31/2024IK051C-0188/ 10/31/2024IK051C-0189/ 10/31/2024IK051C-0190/ 10/31/2024IK051C-0191/ 10/31/2024IK051C-0192/ 10/31/2024IK051C-0193/ 10/31/2024IK051C-0194/ 10/31/2024IK051C-0195/ 10/31/2024IK051C-0196/ 11/30/2024IK051C-0197/ 12/31/2024
- Amount recalled
- 3375
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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