Z-2255-2023Class II

NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the...

Name: Z-2255-2023 NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the...
Creator: NeuMoDx Molecular Inc
Published: 2023-05-24
License: https://open.fda.gov/license/

Neumodx Molecular, Inc. / initiated 2023-05-24 / Open, Classified / root cause: manufacturing process

FDA source

NeuMoDx Molecular Inc began a recall of NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx... on 2023-05-24. FDA classified it as Class II and gives the reason as "Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The misplaced label may interfere with the...". 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-2255-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-24
Posted: 2023-07-28
Recalling firm: Neumodx Molecular, Inc.
Product: NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx System(s) Ref: 100100
Product code: PPM General Purpose Reagent
Reason for recall: Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The misplaced label may interfere with the module s optics performance, thereby increasing the risk for false positive results
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Qiagen issued customers "Urgent: Medical Device Correction" Letter via email on 5/24/23. Letter states reason for recall, health risk and action to take: If you have remaining stock of cartridges LOT 117514, 117524 or 117528, REF 100100, do not use it. Please contact QIAGEN Technical Service for a free-of-charge replacement. Dispose of the product LOT 117514, 117254, and 117528 in accordance with your national and local safety and environmental regulations. If you have already used NeuMoDx Cartridges from this LOT, please review all results obtained with the laboratory director and assess whether retesting is required. Review this notice with your laboratory/medical director. Important: Forward this information to all individuals and departments within your organization using the above listed cartridges. If you are not the end user, please forward this notice to the product end user. Complete Acknowledgement of Receipt attached to this letter by as soon as possible. If you have any questions or concerns, please contact your local QIAGEN Technical Service Department through any of the following: www.qiagen.com/QIAGEN-Subsidiaries.
Quantity in commerce: 20,016 cartridges
Distribution: US Nationwide Distribution to states of: Kansas, Florida, Texas, Ohio, New York, Michigan, Pennsylvania; and OUS (Foreign) to countries of: AT, BE, CH, DE, ES, FI, FR, GB, IT, LV, PL, RO, SE
Product codes and lots: GTIN: 10814278020274 Lot Numbers: 117514, 117524, and 117528

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2255-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2255-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-28

Product code PPM

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)