FDA Medical Device Recalls (openFDA)
Luminex Molecular Diagnostics Inc: NxTAG Respiratory Pathogen Panel, REF: I051C0447
- Recall number
- Z-0042-2025
- Recalling firm
- Luminex Molecular Diagnostics Inc
- Product
- NxTAG Respiratory Pathogen Panel, REF: I051C0447
- Status
- Open, Classified
- Initiated
- 2024-09-05
- Posted
- 2024-10-09
- Terminated
- not on file
- Reason
- 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
- 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 support@luminexcorp.com 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). support@luminexcorp.com www.diasorin.com
- Quantity
- 3375
- 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.
- Lot, serial or model codes
- UDI-DI: 00840487100417. Lot/Expiration: IK051C-0181/ 9/30/2024, IK051C-0182/ 9/30/2024, IK051C-0185/ 9/30/2024, IK051C-0186/ 9/30/2024, IK051C-0187/ 10/31/2024, IK051C-0188/ 10/31/2024, IK051C-0189/ 10/31/2024, IK051C-0190/ 10/31/2024, IK051C-0191/ 10/31/2024, IK051C-0192/ 10/31/2024, IK051C-0193/ 10/31/2024, IK051C-0194/ 10/31/2024, IK051C-0195/ 10/31/2024, IK051C-0196/ 11/30/2024, IK051C-0197/ 12/31/2024
- 510(k) numbers
- ["K193167","K152386"]
- PMA numbers
- not on file
- Product code
- OCC
- Firm FEI
- 3002777243
- Firm city
- Toronto
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28