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
Check against the official notice below — it lists the full affected range.
Microbiologics Inc is recalling its Cepheid Xpert GBS QC Set (catalog number 8164) and Cepheid Smart GBS QC Set (catalog number 8165) because the Lactobacillus acidophilus negative control included in these sets tested positive for Group B Streptococcus in some cases. A total of 541 units were distributed nationwide across 28 states. The affected lot numbers for the 8164 set are 8164-45, 8164-46, 8164-47, 8164-48, and 8164-49, with expiration dates ranging from December 16, 2015 to October 3, 2016.
When used as quality control for Cepheid Xpert GBS and Cepheid Smart GBS testing systems, the contaminated negative control causes the quality control test to fail, disrupting laboratory operations and potentially requiring repeated testing or alternative test methods. The product recall notice does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 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. Quantity: 541 units Lot/code info: 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 record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.