# FDA recall Z-0457-2022

> **DiaSorin Molecular LLC** · Class II · device recall initiated 2021-11-19.

## Product

Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455

## Reason for recall

A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.

## Distribution

US:  AZ,  CA,  CO,  CT,  DC,  FL,  GA,  HI,  IA,  IL,  IN,  KS,  KY,  LA,  MA,  MD,  ME,  MI,  MN,  MO,  NC,  ND,  NE,  NH,  NJ,  NM,  NV,  NY,  OH,  PA,  RI,  SC,  SD,  TN,  TX,  VA,  VT,  WA,  WI,  WV; and      Worldwide:  Kuwait,  Australia,  Israel,  Italy,  Canada,  Chile,  Puerto Rico,  United Arab Emirates.

## Key facts

- **Recall number:** Z-0457-2022
- **Recalling firm:** DiaSorin Molecular LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-11-19
- **Report date:** 2022-01-12

- **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-0457-2022

## Citation

> AI Analytics. FDA recall Z-0457-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0457-2022. Source: US FDA. Licensed CC0.

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