NeuMoDx Cartridge, For In Vitro Diagnostic Use on the… recallZ-1978-2021 · NeuMoDx Molecular Inc · initiated May 4, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from NeuMoDx Molecular Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.
FDA root cause category: Material/Component Contamination
What the company is doing
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 [email protected] 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 [email protected]
Recall details
- Recall number
- Z-1978-2021
- Status
- Terminated
- Initiated by the company
- May 4, 2021
- Recalling firm
- NeuMoDx Molecular Inc
- Quantity
- 620 cases (29,760 cartridges total)
- Product code
- QJR
- Distribution
- Worldwide distribution.
Product description
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
Code information (models, lots, serial numbers)
GTIN: 10814278020274; Lot Numbers: 106629 106630 106631 106632
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NeuMoDxTM Cartridge 100100Neumodx Molecular, Inc. · General purpose reagent3 recalls5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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