QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set… recallZ-0703-2022 · Microbiologics Inc · initiated Dec 1, 2015

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Microbiologics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Material/Component Contamination

What the company is doing

Microbiologics notified customers on about 12/01/2015, via letter titled "MEDICAL DEVICE RECALL." Instructions to customers included verify lots in inventory, cease use of affected product, quarantine affected product, arrange for the return of affected product, and complete and return the response form.

Recall details

Recall number: Z-0703-2022
Status: Terminated
Initiated by the company: Dec 1, 2015
Recalling firm: Microbiologics Inc
Quantity: 541 units
Product code: JTR
FDA submissions: K861022
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.

Product description

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

Code information (models, lots, serial numbers)

Catalog Number: 8164; Lot Number (Expiration Date): 8164-45 (12/16/2015), 8164-46 (12/16/2015), 8164-47 (09/02/2016), 8164-48 (09/02/2016), and 8164-49 (10/03/2016); UDI: 70845357028623

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

QC Sets and Panels: KWIK-STIK™ 8164
Microbiologics Inc. · Multi-analyte controls unassayed
2 recalls0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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