Recall Z-0703-2022— Microbiologics Inc

Name: FDA recall Z-0703-2022
Creator: U.S. Food and Drug Administration
Published: 2015-12-01

Class II · Terminated

Class II FDA medical device recall by Microbiologics Inc, initiated 2015-12-01, terminated 2022-07-07. It names one FDA 510(k) clearance: K861022. Product: 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. Reason: 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..

Recalling firm: Microbiologics Inc
Classification: Class II
Status: Terminated
Initiated: 2015-12-01
Terminated: 2022-07-07
Firm location: Saint Cloud, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K861022 — KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMSMicro-Bio-Logics·cleared 1986-04-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.