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
Check against the official notice below — it lists the full affected range.
Microbiologics Inc. is recalling KWIK-STIK Cepheid Smart GBS QC Sets (catalog number 8165, lot number 8165-25 with expiration date 06/16/2016) distributed nationwide. The Lactobacillus acidophilus negative control component in these sets was found to test positive for Group B Streptococcus in some cases, which is not the expected result for a negative control.
When this contaminated negative control is used with Cepheid Xpert GBS or Cepheid Smart GBS testing systems, it causes the quality control test to fail. This disruption prevents laboratories from completing their testing procedures and may require them to run tests repeatedly or use alternative testing methods. The recall affects 8 units that were distributed across 29 states. The source 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: 8 units Lot/code info: Catalog Number: 8165; Lot Number (Expiration Date): 8165-25 (06/16/2016); UDI: 70845357028630
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.