🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: December 1, 2015 Microbiologics Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Microbiologics Inc
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot 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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0703-2022

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