Luminex Molecular Diagnostics Inc recalls NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
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…
Read the official notice →- Date
- 2024-10-16
- Country
- United States
- Brand
- Luminex Molecular Diagnostics Inc
- Product
- NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
- Classification
- Class II
- Units
- U Nationwide distribution in the states of OH, CA, NC, WI, TN, TX, MI, NY, MO,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
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- Check the product name, strength and lot number against the official notice.
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General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
Other drugs & medical recalls in the United States
- 2024-10-16
USMedtronic Navigation, Inc. recalls StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is…
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing…
FDA · DeviceMedtronic Navigation, Inc.Worldwide - U.S Nationwide distribution including in the states of AK, AR, AZ,…Official notice →- US
Cook Incorporated recalls Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to…
Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
FDA · DeviceCook IncorporatedInternational distribution to the country of Australia.Official notice → - US
Howmedica Osteonics Corp. recalls MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Australia, Germany.Official notice → - US
Inspire Medical Systems Inc. recalls Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
FDA · DeviceInspire Medical Systems Inc.Worldwide distribution - US Nationwide and the countries of Belgium,…Official notice → - US
GE Healthcare recalls GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129;…
GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The issue may occur when a study…
- US
3M Company - Health Care Business recalls 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Contamination with foreign substance matter
FDA · Device3M Company - Health Care BusinessInternational distribution to the country of South Korea.Official notice →