# FDA recall Z-2287-2019

> **Luminex Corporation** · Class II · device recall initiated 2019-02-20.

## Product

ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059

## Reason for recall

Through internal investigation, it was discovered that  a portion  of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.

## Distribution

US: AK, AL, AZ,CA,CO,FL,GA,IL,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,NE,NJ,NM,NY,OH,ON,OR,PA,TN,TX,UT,VA,VT,WA,WI,    OUS: Belgium, Canada, Thailand, Germany, Singapore, United Kingdom

## Key facts

- **Recall number:** Z-2287-2019
- **Recalling firm:** Luminex Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-02-20
- **Report date:** 2019-08-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Austin, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2287-2019

## Citation

> AI Analytics. FDA recall Z-2287-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2287-2019. Source: US FDA. Licensed CC0.

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