# FDA recall Z-0162-2022

> **DiaSorin Molecular LLC** · Class II · device recall initiated 2021-09-23.

## Product

SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051

## Reason for recall

Due to unapproved raw materials  used in the manufacturing  of Covid-19 control pack, their is the potential for delayed amplification signals.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OH, OK, PA, SD, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Italy.

## Key facts

- **Recall number:** Z-0162-2022
- **Recalling firm:** DiaSorin Molecular LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-23
- **Report date:** 2021-10-27

- **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-0162-2022

## Citation

> AI Analytics. FDA recall Z-0162-2022. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-0162-2022. Source: US FDA. Licensed CC0.

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