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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91504

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 30, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
DiaSorin Molecular LLC

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

2 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 2

Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2

Z-1209-2023
Recall number
Z-1209-2023
Initiated
January 30, 2023
Classification
Class II
Status
Ongoing
Recalling firm
DiaSorin Molecular LLC
Quantity
90142

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.

Code information

UDI-DI: 20816101027020. Product REF/Lot/Reaction Mix REF/Lot: MOL4150/US13950/MOL4151/US14091, MOL4150/US14913/MOL4151/US14063, MOL4150/US13952/MOL4151/US14065, MOL4150/US13955/MOL4151/US14086, MOL4150/US13959/MOL4151/US14088, MOL4150/US13956/MOL4151/US14087, MOL4150/US13960/MOL4151/US14093, MOL4150/US13961/MOL4151/US14094, MOL4150/US13973/MOL4151/US13732, MOL4150/US13974/MOL4151/US13736, MOL4150/US14006/MOL4151/US13738, MOL4150/US14004/MOL4151/US15064, MOL4150/US14005/MOL4151/US13737, MOL4150/US14008/MOL4151/US14100, MOL4150/US14007/MOL4151/US14099, MOL4150/US14010/MOL4151/US14102, MOL4150/US14011/MOL4151/US14103, MOL4150/US14012/MOL4151/US15290, MOL4150/US14018/MOL4151/US14111, MOL4150/US14009/MOL4151/US14101, MOL4150/US14017/MOL4151/US14109, MOL4150/15061N/MOL4151/13474N, MOL4150/X15475N/MOL4151/X15479N, MOL4150/13330N/MOL4151/14829N, MOL4150/13331N/MOL4151/13751N, MOL4150/13336N/MOL4151/13752N, MOL4150/13968N/MOL4151/14036N, MOL4150/14346N/MOL4151/14038N, MOL4150/13967N/MOL4151/15082N

Distribution pattern

US Nationwide distribution including in the states of NJ, ME, ND, IL, MI, FL, GA, AZ, MA, CA, MO, SD, MN, PA, OH, VT, NE, WI, CO, DC, VA, TX, NH, IN, IA, MD, NC, AL, NY, KY, WV, RI, KS, NM, OK, WA, SC, CT, TN, NV, LA.

device · product 2 of 2

Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.

Z-1210-2023
Recall number
Z-1210-2023
Initiated
January 30, 2023
Classification
Class II
Status
Ongoing
Recalling firm
DiaSorin Molecular LLC
Quantity
4142

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.

Code information

UDI-DI: 20816101026962. Product REF/Lot/Reaction Mix REF/Lot: MOL2655/13648N/MOL2656/13649N, MOL2655/13882N/MOL2656/15164N, MOL2655/15279N/MOL2656/15280N

Distribution pattern

US Nationwide distribution including in the states of NJ, ME, ND, IL, MI, FL, GA, AZ, MA, CA, MO, SD, MN, PA, OH, VT, NE, WI, CO, DC, VA, TX, NH, IN, IA, MD, NC, AL, NY, KY, WV, RI, KS, NM, OK, WA, SC, CT, TN, NV, LA.