Z-0704-2022Class II

QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus...

Name: Z-0704-2022 QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus...
Creator: Microbiologics Inc
Published: 2015-12-01
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2015-12-01 / Terminated / root cause: manufacturing process

FDA source

Microbiologics Inc began a recall of 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... on 2015-12-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0704-2022
Classification: Class II
Status: Terminated
Initiated: 2015-12-01
Posted: 2022-03-01
Terminated: 2022-07-07
Recalling firm: Microbiologics, Inc.
Product: 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
Product code: JTR Kit, Quality Control For Culture Media
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: 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.
Quantity in commerce: 8 units
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 codes and lots: Catalog Number: 8165; Lot Number (Expiration Date): 8165-25 (06/16/2016); UDI: 70845357028630

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0704-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0703-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-03-01
Z-0704-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-03-01

Product code JTR

K861022Class IKwik Stik(tm) Lyfo(tm) Disk MicroorganismsMicro-Bio-Logics / cleared 1986-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)