Z-1000-2022Class II

NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following...

Name: Z-1000-2022 NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following...
Creator: NeuMoDx Molecular Inc
Published: 2022-02-18
License: https://open.fda.gov/license/

Neumodx Molecular, Inc. / initiated 2022-02-18 / Open, Classified / root cause: manufacturing process

FDA source

NeuMoDx Molecular Inc began a recall of NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test Strip (REF 300800)... on 2022-02-18. FDA classified it as Class II and gives the reason as "Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used in conjunction with assays containing SARS-CoV-2 targets (NeuMoDx" SARS-CoV-2 Test Strip Cat #300800 and NeuMoDx" Flu...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1000-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-18
Posted: 2022-04-22
Recalling firm: Neumodx Molecular, Inc.
Product: NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test Strip (REF 300800) NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip (REF 300900) NeuMoDx Laboratory Developed Tests (LDTs) for SARS-CoV-2 RNA detection Note: Results for targets other than SARS-CoV-2 are not impacted by this Urgent Medical Device Correction Ref. Number: 100100
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Reason for recall: Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used in conjunction with assays containing SARS-CoV-2 targets (NeuMoDx" SARS-CoV-2 Test Strip Cat #300800 and NeuMoDx" Flu A-B/RSV/SARS-CoV-2 Vantage Assay Cat #300900) result incorrect management of patients
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: QIAGEN issued customer Urgent Medical Device Correction notification via email firstly by English (then in local language if required)on 2/18/22. Letter states reason for recall, health risk and action to take: 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 Field Safety Corrective Action with all users of the NeuMoDx Cartridges in your facility to ensure they are aware of this notice. 3. If you have already used NeuMoDx Cartridges from any of these lots in combination with the NeuMoDx SARS-CoV-2 Assay, the NeuMoDx Flu-A-B/RSV/SARS-CoV-2 Assay and NeuMoDx Laboratory Developed Tests (LDTs) for SARS-CoV-2 RNA detection 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 Urgent Field Safety Corrective Action. 4. Complete the attached response form and return to [email protected] to confirm receipt of this notification. If you have any questions regarding this notice, please contact QIAGEN Technical Services at 1-800-362-7737 or [email protected]
Quantity in commerce: 773 (72 US and 701 ROW) cases (48 cartridges/case)
Distribution: Worldwide distribution - US Nationwide distribution in the states of OH, MO, VA, MI, MI, FL, MD, IA, NY, MO and the countries of Italy, Germany, Switzerland, Sweden, Netherlands, Finland, Spain, United Kingdom, Belgium, Austria, Hong Kong, France, Denmark, Slovenia.
Product codes and lots: Lot Numbers: 115424, 115425, 115426, 115427, 115429, 115431. GTIN: 10814278020274

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1000-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1000-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-04	2022-04-22

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)