Xpert MRSA/SA Blood Culture GXMRSA/SA-BC-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07332940000141), received between Mar 28, 2018 and Feb 5, 2026 — classified as 2 deaths, 4 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (5 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026False Negative Result

  US CUSTOMER CONTACTED CEPHEID TO REPORT A QUESTIONABLE NEGATIVE RESULT ON PERT MRSA/SA BC ASSAY. THE CUSTOMER REPORTED STAPHYLOCOCCUS AUREUS WAS IDENTIFIED BY MALDI TOF, BUT INITIAL AND REPEAT EXPERT MRSA/SA BC TESTS WERE SA NEGATIVE. THE BLOOD CULTURE WAS COLLECTED ON (B)(6) 2026, FLAGGED POSITIVE ON (B)(6) 2026 AT 03:27, AND TESTING WAS PERFORMED FROM THE AEROBIC BD BACTEC PLUS BOTTLE. THE LABORATORY FOLLOWED IFU, PERFORMED GRAM STAIN (GRAM POSITIVE COCCI IN CLUSTERS OBSERVED), AND USED ROUTINE CULTURE PLATES (BAP, CHOC, MAC). NO MIXED CULTURE WAS NOTED. SUSCEPTIBILITY TESTING (MICROSCAN WALKAWAY) WAS COMPLETED (OXACILLIN SUSCEPTIBLE) AND REPORTED TO THE PHYSICIAN. REPEAT EXPERT MRSA/SA BC TESTING WAS PERFORMED BECAUSE ITS RESULTS DID NOT CORRELATE WITH MALDI TOF IDENTIFICATION. THE SPECIMEN FOR REPEAT TESTING WAS STORED IN NON CO2 INCUBATION FOR 24 HOURS. THE PATIENT WAS 89 YEARS OLD WITH DIABETES AND VASCULAR DISEASE; IMMUNOCOMPROMISED STATUS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED AND HAS SINCE EXPIRED, BUT NO ADVERSE OUTCOME WAS ATTRIBUTED TO THE TEST DISCREPANCY. NO PATIENT HARM WAS REPORTED, AND THE CUSTOMER CONFIRMED NO ADVERSE OUTCOME ATTRIBUTABLE TO THE DISCREPANCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270697 ↗
• MalfunctionOct 16, 2025False Negative Result; False Negative Result

  CUSTOMER REPORTED DISCREPANT RESULTS FOR SA WHEN TESTING WITH XPERT MRSA SA/BC AND MALDI-TOF MS AS WELL AS OTHER CULTURES. THE CUSTOMER STATED THE PATIENT WAS SYMPTOMATIC AT TIME OF SAMPLE COLLECTION, DID NOT PROVIDE SPECIFIC SYMPTOMS. CUSTOMER SITE PROCEDURE IS TO RUN MALDI-TOF MS FOR RAPID IDENTIFICATION ON SAMPLES THAT DO NOT PRODUCE SA POSITIVE RESULT ON XPERT TEST. CUSTOMER SITE ALSO STATED BCID2 AND PHENOTYPIC RESULTS OF ANTIMICROBIAL SUSCEPTIBILITY TESTING INDICATED MSSA. NO PATIENT HARM WAS REPORTED, HOWEVER THERE WAS A DELAY IN ANTIMICROBIAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23319860 ↗
• MalfunctionJan 27, 2025False Negative Result; False Negative Result

  US CUSTOMER CONTACTED CEPHEID TO DISCUSS DISCREPANT RESULTS FOR A PATIENT USING XPERT MRSA/SA BC. SAMPLE WAS COLLECTED FROM THE PATIENT AND RUN ON XPERT MRSA/SA BC ON (B)(6) 2024 WHICH RESULTED IN MRSA NEGATIVE, SA NEGATIVE. THIS RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RETESTED ON (B)(6) 2024 USING XPERT MRSA/SA BC WHICH RESULTED IN MRSA NEGATIVE, SA NEGATIVE. THIS RESULT WAS REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS RETESTED A SECOND TIME ON (B)(6) 2024 USING XPERT MRSA/SA BC WHICH RESULTED IN MRSA NEGATIVE, SA NEGATIVE. THIS RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RETESTED A THIRD TIME ON (B)(6) 2024 USING XPERT MRSA/SA BC WHICH RESULTED IN MRSA NEGATIVE, SA NEGATIVE. THIS RESULT WAS REPORTED TO THE PHYSICIAN. THE TESTS WERE RUN OFF-LABEL. THE CUSTOMER TESTED BOTH THE AEROBIC AND ANAEROBIC BOTTLE COLLECTED FROM THE PATIENT, CUSTOMER WAS UNABLE TO IDENTIFY WHICH RUNS CORRESPOND TO WHICH BOTTLE OUTSIDE OF THE INITIAL TEST, WHICH WAS RUN WITH THE AEROBIC BOTTLE. CUSTOMER REPORTED THEY HAVE VALIDATED RUNNING THE OFF-LABEL ANAEROBIC BOTTLE WITH XPERT MRSA/SA BC. SAMPLE WAS ALSO STORED AT 35 DEGREES C IN THE BACTEC INCUBATOR BETWEEN TESTS. BOTTLES WERE PL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21246440 ↗
• MalfunctionDec 3, 2024False Negative Result; False Negative Result

  US CUSTOMER CONTACTED CEPHEID TO REPORT DISCREPANT RESULT WITH XPERT MRSA/SA BC. PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH. SAMPLE 1 WAS COLLECTED FROM THE PATIENT ON (B)(6) 2024. ON (B)(6) 2024 SAMPLE WAS RAN ON XPERT MRSA/SA BC WHICH RESULTED IN MRSA NEGATIVE, SA NEGATIVE. THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN. SAMPLE WAS THEN RETESTED ON (B)(6) 2024 USING MALDI-TOF WHICH RESULTED IN STAPH AUREUS POSITIVE. THIS RESULT WAS REPORTED TO THE PHYSICIAN. SAMPLE WAS RETESTED A 2ND TIME USING XPERT MRSA/SA BC WHICH RESULTED IN MRSA NEGATIVE, SA NEGATIVE. THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RETESTED A 3RD TIME ON (B)(6) 2024 USING BD PHOENIX M50 RESULTING SUSCEPTIBLE. THIS RESULT WAS REPORTED TO THE PHYSICIAN. SAMPLES WERE PROCESSED PER PACKAGE INSERT. THE BOTTLE WAS IN THE INCUBATOR FOR APPROXIMATELY 7 HOURS BEFORE BEING PULLED OUT AFTER BEING FLAGGED POSITIVE. GRAM STAIN PERFORMED AND GRAM-POSITIVE COCCI IN CLUSTERS OBSERVED. BLOOD, MACCONKEY, CNA, CHOCOLATE, AND CDC AGAR USED FOR CULTURE. NO MIXED CULTURE OBSERVED. MALDI IDENTIFIED AS STAPH AUREUS. CEPHEID RESULT WAS MRSA NEGATIVE, S. AUREUS NEGATIVE, WHICH PROMPTED THE RET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20835216 ↗
• DeathMay 10, 2024False Negative Result; False Negative Result

  US CUSTOMER CONTACTED CEPHEID TO DISCUSS A DISCREPANT RESULT WHERE THE INITIAL RESULTS WERE MRSA AND SA NEGATIVE, AND THE REPEAT RUN WAS MRSA AND SA POSITIVE. THE SITE COLLECTED A BLOOD SAMPLE FROM PATIENT ON (B)(6) 2024. THE SITE CONFIRMED THEY USED A BD BACTEC PLUS BOTTLE TO INCUBATE THE SAMPLE, AND THEY STATED THEY USED BOTH AN AEROBIC AND ANAEROBIC BOTTLE FOR PATIENT SAMPLE. THE BOTTLES WERE IN THE INCUBATOR FOR LESS THAN A DAY BEFORE THEY FLAGGED POSITIVE ACCORDING TO THE SITE. NO TIME WAS PROVIDED OR CONFIRMATION WHETHER BOTH OR JUST ONE BOTTLE FLAGGED POSITIVE, BUT SITE STATED IT FLAGGED POSITIVE ON (B)(6)2024 AND WAS HELD AT ROOM TEMPERATURE ONCE TAKEN OUT OF THE INCUBATOR. SITE STATED A GRAM STAIN WAS PERFORMED AND IT WAS POSITIVE FOR GRAM COCCI CLUSTERS. ON (B)(6)2024 PATIENT 1 SAMPLE 1 WAS RUN ON THE XPERT MRSA_SA_BC, AND THE RESULTS WERE MRSA NEGATIVE SA NEGATIVE. THESE RESULTS WERE REPORTED TO THE PHYSICIAN. THE SITE STATED THEY FOLLOWED THE IFU. ON (B)(6)2024 PATIENT 1 SAMPLE 2 WAS RUN ON THE XPERT MRSA_SA_BC, AND THE RESULTS WERE MRSA POSITIVE SA POSITIVE. IT WAS NOT CONFIRMED BY SITE THAT THESE RESULTS WERE REPORTED TO THE PHYSICIAN. CUSTOMER DID NOT CONFIRM WHETHER

  Patient problems: Cardiac Arrest; Drug Resistant Bacterial Infection; Renal Impairment; Septic Shock

  MAUDE report 19287576 ↗
• DeathMar 28, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THIS CASE CONCERNED A DISCREPANCY BETWEEN (B)(6) RESULTS, WHICH WERE INITIALLY REPORTED (B)(6) / (B)(6) ON (B)(6) 2018. THE FOLLOWING DAY ((B)(6) 2018), (B)(6) GREW IN CULTURE AND WAS CONFIRMED AS (B)(6) BY MICROSCAN AND DISK DIFFUSION. THE BLOOD CULTURE BOTTLE WAS RETESTED AND WAS DETERMINED TO BE (B)(6) BY (B)(6) (LIKELY A MUTATION WITHIN (B)(6) TARGETS PROBE OR BINDING SITES). ACCORDING TO THE LAB, THERE WAS A DELAY IN REPORTING (B)(6) BY APPROXIMATELY 24 HOURS AND DURING THIS TIME THE PATIENT WAS NOT ON (B)(6) ACTIVE DRUGS. PATIENT WAS A (B)(6) YEAR OLD MALE FROM A NURSING HOME ADMITTED FOR SEPSIS. PATIENT DIED ON (B)(6) 2018, ALTHOUGH HIS ANTIBIOTIC THERAPY HAD BEEN CHANGED TO THREE DRUGS TO WHICH THE (B)(6) ORGANISM WAS SUSCEPTIBLE. THE DISCREPANT RESULT MAY HAVE CONTRIBUTED TO THE PATIENT'S DEATH. A FOLLOW-UP BLOOD CULTURE USING (B)(6) REPORTED (B)(6) (B)(6).

  Patient problems: Sepsis

  MAUDE report 7380500 ↗