# FDA recall Z-0703-2022

> **Microbiologics Inc** · Class II · device recall initiated 2015-12-01.

## Product

QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture).  Sets include:   1. 0864E3 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401;   2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401;   3. 0864E7 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401;   4. Negative Control 0243 Lactobacillus acidophilus derived from ATCC 4356

## Reason for recall

The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set was found to test positive for Group B Streptococcus (GBS) in some cases. This causes a failure when used as a quality control for the Cepheid Xpert GBS and Cepheid Smart GBS systems. The failure of the quality control test causes a disruption for the testing laboratory which may result in repeated testing or the need for alternative test methods. This recall is applicable to the 8164 and 8165 sets only.

## Distribution

US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MN, NC, NM, NY, OH, OR, PA, TN, TX, VA, VT, WA, WI, WV, WY.

## Key facts

- **Recall number:** Z-0703-2022
- **Recalling firm:** Microbiologics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2015-12-01
- **Report date:** 2022-03-09
- **Termination date:** 2022-07-07

- **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-0703-2022

## Citation

> AI Analytics. FDA recall Z-0703-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0703-2022. Source: US FDA. Licensed CC0.

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