Recall archive / FDA device enforcement
Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2 — FDA record Z-1209-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 30, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- DiaSorin Molecular LLC
- Quantity
- 90142
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1209-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Mar 15, 2023
- Recall initiation date
- Jan 30, 2023
- Center classification date
- Mar 3, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.