Xpert MTB/RIF GXMTB/RIF-US-10Recalls & reported problems
Cepheid · Xpert MTB/RIF kit; 10 test kit · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07332940000912), received between Aug 23, 2024 and Oct 21, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “False Negative Result” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Nov 5, 2025Class IIOpen, Classified
Product testing did not meet expected stability criteria.
Z-0724-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- False Negative Result2
- False Positive Result1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- Cough1
- Hot Flashes/Flushes1
- Wheezing1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2025False Negative Result; False Negative Result
US CUSTOMER CONTACTED CEPHEID TO REPORT 1 PATIENT FOR MTB BETWEEN PCR RESULTS (QUESTIONABLE NEGATIVE) AND CULTURE RESULTS. THAT SAMPLE WAS COLLECTED ON (B)(6) 2025 @3:15 AND REFRIGERATED @2-8 C ONCE BROUGHT TO THE LAB. SAMPLE WAS RUN ON (B)(6) 2025 ON XPERT MTB/RIF. THE PATIENT HAD 3 OTHER SPUTUMS COLLECTED ON THE FOLLOWING DAYS (B)(6) 2025) SENT FOR AFB CULTURES THAT ALSO GREW MYCOBACTERIUM TUBERCULOSIS COMPLEX. THE MTB-RIF PCR TEST WAS NOT TESTED ON THESE SAMPLES BECAUSE OUR PROTOCOL DOES NOT WARRANT TESTING DUE TO ALREADY BEEN PERFORMED ON FIRST SPUTUM WITH POSITIVE SMEAR. SITE DOES NOT HAVE PATIENT SAMPLES ANY LONGER. NO KNOWN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350776 ↗InjuryAug 23, 2024False Positive Result; False Positive Result
B5- US CUSTOMER CONTACTED CEPHEID TO REPORT A QUESTIONABLE POSITIVE RESULT ON XPERT MTB/RIF. PATIENT SPUTUM SEDIMENT SPECIMEN WAS COLLECTED IN A CLEAN CONTAINER ON (B)(6) 2024. SAMPLE WAS DIGESTED, DECONTAMINATED, AND CONCENTRATED PER THE INSTRUCTIONS IN THE PACKAGE INSERT. AN ACID-FAST STAIN WAS PERFORMED, AND THE RESULTS WERE NEGATIVE. THE SAMPLE WAS TESTED WITH XPERT MTB/RIF ON (B)(6) 2024 WHICH RESULTED AS MTB DETECTED; RIF RESISTANCE DETECTED. SAMPLE WAS PROCESSED PER THE PI. THIS RESULT WAS REPORTED TO THE PHYSICIAN. THE INITIAL XPERT MTB/RIF RESULT WAS QUESTIONED BY THE PHYSICIAN. A BLOOD SPECIMEN WAS COLLECTED FROM THE PATIENT AND QUANTIFERON GOLD TESTING WAS PERFORMED, WHICH RESULTED AS NEGATIVE. THE PATIENT'S X-RAYS WERE ALSO NOT CONSISTENT WITH TB, SO PHYSICIAN REQUESTED THE SAMPLE BE RETESTED ON XPERT MTB/RIF. THE SAMPLE WAS RETESTED WITH XPERT MTB/RIF ON (B)(6) 2024 WHICH RESULTED AS MTB NOT DETECTED. SAMPLE WAS STORED REFRIGERATED IN BETWEEN TESTS AND ALLOWED TO COME TO ROOM TEMPERATURE BEFORE PROCESSING. SAMPLE WAS PROCESSED PER THE PI. THIS RESULT WAS REPORTED TO THE PHYSICIAN. TB CULTURE HAS BEEN SET UP AND IS STILL IN PROGRESS, BUT SO FAR THERE IS NO GROWTH. PATIE
Patient problems: Cough; Hot Flashes/Flushes; Insufficient Information; Wheezing
MAUDE report 20048153 ↗InjuryAug 23, 2024False Negative Result; False Negative Result
US CUSTOMER CONTACTED CEPHEID ON (B)(6) 2024 TO REPORT A QUESTIONABLE NEGATIVE RESULT USING XPERT MTB/RIF. COLLECTION 1: ON (B)(6) 2024, AN INDUCED SPUTUM SAMPLE WAS COLLECTED. SPUTUM SEDIMENT WAS TESTED PER PI ON XPERT MTB/RIF ON (B)(6) 2024, WHICH RESULTED IN MTB NOT DETECTED. THIS WAS REPORTED TO THE PHYSICIAN. AFB SMEAR WAS POSITIVE. M. TUBERCULOSIS IDENTIFIED FROM CULTURE. COLLECTION 2: ON (B)(6) 2024, AN INDUCED SPUTUM SAMPLE WAS COLLECTED. SPUTUM SEDIMENT WAS TESTED PER PI ON XPERT MTB/RIF ON (B)(6) 2024, WHICH RESULTED IN MTB NOT DETECTED. THIS WAS REPORTED TO THE PHYSICIAN. AFB SMEAR WAS NEGATIVE. M. TUBERCULOSIS IDENTIFIED FROM CULTURE. COLLECTION 3: ON (B)(6) 2024, AN INDUCED SPUTUM SAMPLE WAS COLLECTED. SPUTUM SEDIMENT WAS TESTED PER PI ON XPERT MTB/RIF ON (B)(6) 2024, WHICH RESULTED IN MTB NOT DETECTED. THIS WAS REPORTED TO THE PHYSICIAN. AFB SMEAR WAS NEGATIVE. M. TUBERCULOSIS IDENTIFIED FROM CULTURE. COLLECTION 4: ON (B)(6) 2024 AN INDUCED SPUTUM SAMPLE WAS COLLECTED. SPUTUM SEDIMENT WAS TESTED PER PI ON XPERT MTB/RIF ON (B)(6) 2024, WHICH RESULTED IN MTB NOT DETECTED. THIS WAS REPORTED TO THE PHYSICIAN. AFB SMEAR WAS NEGATIVE. M. TUBERCULOSIS WAS NOT IDENTIFIED FROM
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20045223 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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