Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Cepheid Smart GBS QC Set

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Cepheid Smart GBS QC Set see related information
Date Initiated by Firm December 01, 2015
Create Date March 01, 2022
Recall Status1 Terminated 3 on July 07, 2022
Recall Number Z-0704-2022
Recall Event ID 89517
510(K)Number K861022  
Product Classification Kit, quality control for culture media - Product Code JTR
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
Code Information Catalog Number: 8165; Lot Number (Expiration Date): 8165-25 (06/16/2016); UDI: 70845357028630
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information Contact Becky Neu
320-229-7073
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JTR and Original Applicant = MICRO-BIO-LOGICS
-
-