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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90275

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 13, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
NeuMoDx Molecular Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900

Z-1251-2022
Recall number
Z-1251-2022
Initiated
May 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
NeuMoDx Molecular Inc
Quantity
459 kits US; 1626 kits OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.

Code information

UDI-DI (GTIN): 10814278020830 Cartridge lot numbers 111915 - 117508

Distribution pattern

Domestic distribution to FL, NY, MD, PA, VA, MI, TN, NM. Foreign distribution to AT, AU, BE, CH, DE, FI, FR, GB, GR, HK, ID, IT, LT, NL, SA, SE, and SI.