NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.

Recall Insight

This FDA Devices action (record #Z-0738-2022) was formally reported on March 16, 2022, with the manufacturer initiating the action on January 21, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. NeuMoDx Molecular Inc is listed as the recalling firm, operating out of Ann Arbor, MI. Federal records indicate 102 boxes units are affected.

The documented reason for this recall is: A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product. Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of FL, MD, MI, NY.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.