NeuMoDx Molecular Inc NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
Brand
NeuMoDx Molecular Inc
Lot Codes / Batch Numbers
GTIN: 10814278020274, Lot Numbers: 106629 106630 106631 106632
Products Sold
GTIN: 10814278020274; Lot Numbers: 106629 106630 106631 106632
NeuMoDx Molecular Inc is recalling NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, due to There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.
Recommended Action
Per FDA guidance
URGENT MEDICAL DEVICE CORRECTION notification letters dated 5/4/21 were sent to customers. Actions Required by Customers 1. IMMEDIATELY discontinue use of the product and discard remaining inventory in accordance with your national and local safety and environmental regulations. Please contact QIAGEN Technical Service for a free-of-charge replacement of scrapped inventory. 2. Share this Medical Device Correction Notice with all users of the NeuMoDxTM Cartridges in your facility to ensure they are aware of this notice. 3. If you have already used NeuMoDxTM Cartridges from any of these lots in combination with the NeuMoDxTM SARS-CoV-2 Assay or the NeuMoDx Flu-A-B/RSV/SARS-CoV-2 Assay, please review all SARS-CoV-2 positive results to exclude erroneous diagnosis and treatment, except in those cases where alternative confirmation was obtained. Note: results for targets other than SARS-CoV-2 are not impacted by this medical device correction. 4. Complete the attached response form and return to Quality.Communications@qiagen.com to confirm receipt of this notification. We sincerely apologize for any inconvenience this may have caused and thank you in advance for your patience and cooperation. If you have any questions regarding this notice, please contact QIAGEN Technical Services at 1-800-362-7737 or techservice-na@qiagen.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026