# FDA recall Z-2153-2023

> **DiaSorin Molecular LLC** · Class II · device recall initiated 2023-06-14.

## Product

Simplexa Direct Amplification Disc Kit, Rx Only, IVD    The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452

## Reason for recall

There is a potential for the direct amplification disc to malfunction  which may result in spillage of liquid from the disc.

## Distribution

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

## Key facts

- **Recall number:** Z-2153-2023
- **Recalling firm:** DiaSorin Molecular LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-14
- **Report date:** 2023-07-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cypress, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2153-2023

## Citation

> AI Analytics. FDA recall Z-2153-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2153-2023. Source: US FDA. Licensed CC0.

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