Xpert GBS LB GXGBS-LB-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07332940000882), received between Jul 12, 2023 and Aug 30, 2023 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  US CUSTOMER CONTACTED CEPHEID TO DISCUSS DISCREPANT RESULTS WITH XPERT GBS LB V1 ASSAY. ON (B)(6) 2023, PATIENT 1 SAMPLE 1 GENITAL SAMPLE WAS COLLECTED FOR ROUTINE GBS TESTING BEFORE DELIVERING HER CHILD. THE SAMPLE WAS RECEIVED BY THE LAB, PLACED INTO LIM BROTH AND INCUBATED OVERNIGHT. ON (B)(6) 2023, A CLEAN SWAB WAS PLACED INTO BROTH AND THEN PUT INTO THE CARTRIDGE AND RAN ON THE XPERT GBS LB ASSAY. THE RESULTS WERE GBS NEGATIVE. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE LAB NO LONGER HAD THIS SPECIMEN, AND THEY DID NOT DO A CULTURE AT THE TIME OF COLLECTION/TESTING. IT IS UNKNOWN IF THE PATIENT WAS ON ANY MEDICATION AS NOTHING WAS CHARTED, OTHER THAN NOTATING SHE WAS ALLERGIC TO RED DYE. AFTER THE BABY WAS BORN, THEY BEGAN SHOWING SYMPTOMS, AND BOTH A BLOOD SAMPLE AND CSF SAMPLE TURNED POSITIVE FOR GBS RESULTS. THE BABY BECAME CRITICALLY ILL. THESE SAMPLES WERE RUN ON BIOFIRE. ON (B)(6) 2023, PATIENT 1 SAMPLE 2S GENITAL SWAB WAS COLLECTED SO THE TEAM COULD RECOLLECT AND RETEST THE MOTHER. A CULTURE WAS CREATED FROM THIS COLLECTION. ON (B)(6) 2023, PATIENT 1 SAMPLE 2 1ST RUN WAS PROCESSED THE SAME WAY AS ABOVE ON THE XPERT GBS LB V1 ASSAY. THE RESULTS WERE GBS NEGATIVE. ON

  Patient problems: Convulsion/Seizure; Meningitis; Respiratory Distress Syndrome of Newborns; Septic Shock

  MAUDE report 17653313 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  US CUSTOMER CONTACTED CEPHEID TO DISCUSS DISCREPANT RESULTS WITH XPERT GBS-LB. ON (B)(6) 2023, THE CUSTOMER COLLECTED A VAGINAL/RECTAL SWAB FROM THE PATIENT. THE CUSTOMER MIXED THE ESWAB WITH INVERSION AND THEN PIPETTED 200UL OF THE ESWAB INTO THE LIM BROTH (REMEL TODD HEWITT W/CNA) AND INCUBATED FOR 18 HOURS. ON (B)(6) 2023, THE CUSTOMER THEN PROCESSED THE LIM BROTH PER PI AND RAN IT ON XPERT GBS-LB, WHICH RESULTED IN GBS NEGATIVE. THIS WAS REPORTED TO THE MD. ON (B)(6) 2023, THE CUSTOMER SUBBED THE ORIGINAL ESWAB TO REMEL SHEEP BLOOD AGAR. ON THE SAME DAY, THE CUSTOMER ALSO DECIDED TO USE THE SAME ESWAB TO INOCULATE A BRAND-NEW LIM BROTH VIAL WITH 200UL OF THE ESWAB. CUSTOMER DID NOT INFORM HOW ORIGINAL SWAB WAS STORED IN BETWEEN INOCULATIONS. DUE TO THE NEWBORN BABY OF THE PATIENT BEING SYMPTOMATIC, THE CUSTOMER DID NOT TRUST THIS RESULT AND DECIDED TO RUN THE ORIGINAL ENRICHED LIM BROTH AGAIN. ON (B)(6) 2023, THE CUSTOMER THEN PROCESSED THE LIM BROTH PER PI AND RAN IT ON XPERT GBS-LB, WHICH RESULTED IN GBS NEGATIVE. THIS WAS NOT REPORTED TO THE MD. THE CUSTOMER THEN DECIDED TO TRY RUNNING THIS SAMPLE AGAIN ON THE ORIGINAL ENRICHED LIM BROTH AGAIN. ON (B)(6) 2023, THE CUSTOMER T

  Patient problems: Feeding Problem; Pulmonary Dysfunction; Septic Shock; Unspecified Respiratory Problem

  MAUDE report 17313221 ↗