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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88099

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

Open FDA event record

Event summary

Timeline bucket
May 04, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
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 Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100

Z-1978-2021
Recall number
Z-1978-2021
Initiated
May 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
NeuMoDx Molecular Inc
Quantity
620 cases (29,760 cartridges total)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

GTIN: 10814278020274; Lot Numbers: 106629 106630 106631 106632

Distribution pattern

Worldwide distribution.