FDA Medical Device Recalls (openFDA)
NeuMoDx Molecular Inc: 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
- Recall number
- Z-2255-2023
- 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
- Status
- Open, Classified
- Initiated
- 2023-05-24
- Posted
- 2023-07-28
- Terminated
- not on file
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- GTIN: 10814278020274 Lot Numbers: 117514, 117524, and 117528
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PPM
- Firm FEI
- 3010729479
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28