Z-1978-2021Class II

NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model...

Name: Z-1978-2021 NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model...
Creator: NeuMoDx Molecular Inc
Published: 2021-05-04
License: https://open.fda.gov/license/

Neumodx Molecular, Inc. / initiated 2021-05-04 / Terminated / root cause: manufacturing process

FDA source

NeuMoDx Molecular Inc began a recall of NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100 on 2021-05-04. FDA classified it as Class II and gives the reason as "There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1978-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-04
Posted: 2021-06-29
Terminated: 2022-06-21
Recalling firm: Neumodx Molecular, Inc.
Product: NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Reason for recall: There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: 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]
Quantity in commerce: 620 cases (29,760 cartridges total)
Distribution: Worldwide distribution.
Product codes and lots: GTIN: 10814278020274; Lot Numbers: 106629 106630 106631 106632

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1978-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1978-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-06-29

Product code QJR

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)