Home / Recalls / NeuMoDx Molecular Inc / Z-1978-2021

Z-1978-2021 Class II Terminated

Recalled by NeuMoDx Molecular Inc — Ann Arbor, MI

Recall Details

Product Type
Devices
Report Date
July 7, 2021
Initiation Date
May 4, 2021
Termination Date
June 21, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
620 cases (29,760 cartridges total)

Product Description

NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100

Reason for Recall

There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.

Distribution Pattern

Worldwide distribution.

Code Information

GTIN: 10814278020274; Lot Numbers: 106629 106630 106631 106632

Other recalls by NeuMoDx Molecular Inc

  • Z-2255-2023 Class II — NeuMoDx Cartridge-used for extraction, purification, amplification and detection (May 24, 2023)
  • Z-2093-2023 Class III — NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-Co (May 15, 2023)
  • Z-1251-2022 Class II — NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900 (May 13, 2022)
  • Z-1000-2022 Class II — NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems w (February 18, 2022)
  • Z-0738-2022 Class II — NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under (January 21, 2022)