NxTAG Respiratory Pathogen Panel recall
NxTAG Respiratory Pathogen Panel, REF: I051C0447
Why was NxTAG Respiratory Pathogen Panel 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- NxTAG Respiratory Pathogen Panel, REF: I051C0447
- Recalling firm
- Luminex Molecular Diagnostics Inc
- 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.
- Recall date
- October 16, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)