# FDA recall Z-0982-2019

> **Microbiologics Inc** · Class II · device recall initiated 2019-01-31.

## Product

Cepheid Respiratory Control Panel  Catalog #8199  for in vitro diagnostic use

## Reason for recall

Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.

## Distribution

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI, WV.        International distribution to Austria, Canada, Finland, Ireland, Malaysia, New Zealand, Portugal, South Africa, Sweden, Switzerland, United Kingdom.

## Key facts

- **Recall number:** Z-0982-2019
- **Recalling firm:** Microbiologics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-31
- **Report date:** 2019-03-13
- **Termination date:** 2020-06-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Cloud, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0982-2019

## Citation

> AI Analytics. FDA recall Z-0982-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0982-2019. Source: US FDA. Licensed CC0.

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