Z-0043-2025Class II

NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468

Name: Z-0043-2025 NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Creator: Luminex Molecular Diagnostics Inc
Published: 2024-09-05
License: https://open.fda.gov/license/

Luminex Molecular Diagnostics Inc / initiated 2024-09-05 / Open, Classified / root cause: design

FDA source

Luminex Molecular Diagnostics Inc began a recall of NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468 on 2024-09-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0043-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-05
Posted: 2024-10-09
Recalling firm: Luminex Molecular Diagnostics Inc
Product: NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Product code: QLT Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: On 9/5/24, recall notices were sent to customers and distributors were were asked to do the following: 1. Two options are available to overcome the sporadic potential risk of the hMPV false positive result: A. Continue to use the product as per its instruction for use: in case of a positive result for hMPV, consider performing confirmatory testing with another method before reporting the hMPV result, if medically indicated. B. Exclude the hMPV from the reporting by removing this target from the assay analysis, as explained in the package insert under the chapter "Define Test Panels in SYNCT Software". See Document No. and Revision/Page reference: MLD-051-KPI-001 Rev H/Page 17, MLD-056-KPI-001 Rev. E/Page 18. 2. Notify others within your network that may have remaining inventory of those kits. 3. If you are a distributor, provide a copy of this letter to customers or organizations who received impacted lots. 4. Complete and return the response form via email to [email protected] 5. For complaints, questions, or concerns, please contact Technical Support using the contact information: 1-877-785-2323 (U.S. and Canada). +1-512-381-4397 (Outside U.S. and Canada). 1-512-219-5114 (Fax). [email protected] www.diasorin.com
Quantity in commerce: 613
Distribution: U Nationwide distribution in the states of OH, CA, NC, WI, TN, TX, MI, NY, MO, FL, MA, NJ, PA, VA, AZ, IL, OK, CO, MN.
Product codes and lots: Lot/Expiration: IK056C-0033/ 9/30/2024, IK056C-0034/ 10/31/2024, IK056C-0035/ 10/31/2024, IK056C-0036/ 12/31/2024, IK056C-0037/ 12/31/2024, IK056C-0038/ 12/31/2024, IK056C-0039/ 1/31/2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0043-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0042-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-16	2024-10-09
Z-0043-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-16	2024-10-09

Product code QLT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)