Z-0704-2022 Class II Terminated
FDA device recall Z-0704-2022 was initiated by Microbiologics Inc on Dec 1, 2015 and is designated Class II. 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… The recall status is terminated (terminated Jul 7, 2022). Affected quantity: 8 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 9, 2022
- Initiation Date
- Dec 1, 2015
- Termination Date
- Jul 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 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 Pattern
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.
Code Information
Catalog Number: 8165; Lot Number (Expiration Date): 8165-25 (06/16/2016); UDI: 70845357028630
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0704-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026