Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge 20-006-018Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00840487101575), received between Nov 20, 2020 and Jul 24, 2024 — classified as 1 death, 14 malfunctions.

The most frequently reported specific device problem is “False Positive 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.

Recalls naming this device

1. Jun 20, 2024Class IIOpen, Classified

   Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.

   Z-2533-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2024No Apparent Adverse Event; No Apparent Adverse Event

  ON 6/23/2024 CUSTOMER (B)(6) MEDICAL CENTER BROWNWOOD REPORTED A DISCREPANT RESULT ON BC-GP ASSAY IN RESPONSE TO FSN-0005. VERIGENE DETECTED STAPHYLOCOCCUS LUGDUNENSIS, HOWEVER MALDI-TOF DETECTED CORYNEBACTERIUM STRIATUM. VERIGENE: STAPHYLOCOCCUS LUDGUNESIS AND ENTEROCOCCUS FAECIUM DETECTED. CULTURE: STREPTOCOCCUS GALLOLYTICUS DETECTED. MALDI-TOF: CORYNEBACTERIUM STRIATUM DETECTED. DATA REVIEW: PER VERIGENE ID SOFTWARE REQUIREMENTS SPECIFICATION (TOAST-SRS-1042), IN ORDER FOR AN ORGANISM TO BE DETECTED THE IC RATIO MUST BE GREATER THAN OR EQUAL TO -0.4 AND THE NC RATIO MUST BE GREATER THAN 0.85. REVIEW OF TEST CARTRIDGE (B)(4) SHOWS STAPHYLOCOCCUS LUDGUNESIS DETECTED AT EXPOSURE 1200MS (IC: -0.28 NC: 0.87). PC1 WAS DETECTED AT EXPOSURE 24MS (IC: 0.53 NC: 0.99) AND PC 2 WAS DETECTED AT EXPOSURE 24MS WITH IC AND NC VALUES OF 0.23 AND 0.98 RESPECTIVELY. CAMERA IMAGES WERE CLEAR WITH SUSPECTED NO IMPACT ON RESULTS. TEST WAS COMPLETED ON (B)(6) 2024. CONSUMABLE REVIEW: TEST CARTRIDGE LOT: 031824018A. EXTRACTION TRAY LOT: 031124018B. UTILITY TRAY LOT: 030824018C. THERE ARE NO NCS ASSOCIATED WITH THE LOTS UTILIZED. THERE ARE 25 OTHER ERRONEOUS RESULTS REPORTED FOR THE STAPHYLOCOCCUS LUDGU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817898 ↗
• MalfunctionJul 2, 2024No Apparent Adverse Event; No Apparent Adverse Event

  EVENT DESCRIPTION (WHAT IS REPORTED): ON 6/5/2024 CUSTOMER (B)(6) LAB REPORTED A DISCREPANT RESULT ON BC-GP ASSAY. VERIGENE DETECTED STAPHYLOCOCCUS SPECIES AND STAPHYLOCOCCUS LUGDUNENSIS HOWEVER CULTURE SHOWED STAPHYLOCOCCUS CAPITIS DETECTED. VERIGENE: STAPHYLOCOCCUS SPECIES AND STAPHYLOCOCCUS LUDGUNESIS DETECTED. CULTURE: STAPHYLOCOCCUS CAPITIS DETECTED. DATA REVIEW PER VERIGENE ID SOFTWARE REQUIREMENTS SPECIFICATION (TOAST-SRS-1042), IN ORDER FOR AN ORGANISM TO BE DETECTED THE IC RATIO MUST BE GREATER THAN OR EQUAL TO -0.4 AND THE NC RATIO MUST BE GREATER THAN 0.85. REVIEW OF TEST CARTRIDGE 01864078 SHOWS STAPHYLOCOCCUS SPECIES DETECTED AT EXPOSURE 150 (IC: -0.03 NC: 0.96) AND STAPHYLOCOCCUS LUDGUNESIS DETECTED AT EXPOSURE 1200 (IC: -0.22 NC: 0.88). PC1 WAS DETECTED AT EXPOSURE 24 (IC: 0.51 NC: 0.98) AND PC 2 WAS DETECTED AT EXPOSURE 150 WITH IC AND NC VALUES OF 0.05 AND 0.97 RESPECTIVELY. CAMERA IMAGES WERE NOT AVAILABLE. THIS WAS TESTED ON 6/1/2024 ON SP A3. CONSUMABLE REVIEW TEST CARTRIDGE LOT: 031824018A EXTRACTION TRAY LOT: 031124018B UTILITY TRAY LOT: 030824018C THERE ARE NO NCMRS ASSOCIATED WITH THE LOTS UTILIZED. THERE ARE 24 OTHER ERRONEOUS RESULTS REPORTED FOR THE STAPH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19657842 ↗
• MalfunctionJul 2, 2024No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2024 CUSTOMER (B)(6) CLIN LAB REPORTED A DISCREPANT RESULT ON BC-GP ASSAY. VERIGENE DETECTED STAPHYLOCOCCUS SPECIES, STAPHYLOCOCCUS LUGDUNENSIS, AND STAPHYLOCOCCUS EPIDERMIDIS HOWEVER CULTURE SHOWED STAPHYLOCOCCUS EPIDERMIDIS DETECTED. VERIGENE: STAPHYLOCOCCUS SPECIES, STAPHYLOCOCCUS LUDGUNESIS, AND STAPHYLOCOCCUS EPIDERMIDIS DETECTED. CULTURE: STAPHYLOCOCCUS EPIDERMIDIS DETECTED. DATA REVIEW PER VERIGENE ID SOFTWARE REQUIREMENTS SPECIFICATION (TOAST-SRS-1042), IN ORDER FOR AN ORGANISM TO BE DETECTED THE IC RATIO MUST BE GREATER THAN OR EQUAL TO -0.4 AND THE NC RATIO MUST BE GREATER THAN 0.85. REVIEW OF TEST CARTRIDGE 01864095 SHOWS STAPHYLOCOCCUS SPECIES DETECTED AT EXPOSURE 24 (IC: 0.84 NC:0.99), STAPHYLOCOCCUS EPIDERMIDIS DETECTED AT EXPOSURE 24 (IC: 0.63 NC: 0.98), AND STAPHYLOCOCCUS LUDGUNESIS DETECTED AT EXPOSURE 150 (IC: -0.27 NC: 0.98). PC1 WAS DETECTED AT EXPOSURE 24 (IC: 0.46 NC: 0.97) AND PC 2 WAS DETECTED AT EXPOSURE 150 WITH IC AND NC VALUES OF 0.14 AND 0.94 RESPECTIVELY. CAMERA IMAGES WERE NOT AVAILABLE. THIS WAS TESTED ON (B)(6) 2024 ON SP A2. CONSUMABLE REVIEW TEST CARTRIDGE LOT: 031824018A, EXTRACTION TRAY LOT: 031124018B, UTILITY TRAY LOT: 030824018C. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19657834 ↗
• MalfunctionJul 2, 2024No Apparent Adverse Event; No Apparent Adverse Event

  EVENT DESCRIPTION (WHAT IS REPORTED): ON (B)(6) 2024 CUSTOMER ST JOSEPHS HEALTH CLIN LAB REPORTED A DISCREPANT RESULT ON BC-GP ASSAY. VERIGENE DETECTED STAPHYLOCOCCUS LUGDUNENSIS AND ENTEROCOCCUS FAECIUM HOWEVER CULTURE SHOWED STAPHYLOCOCCUS GALLOLYTICUS DETECTED. VERIGENE: STAPHYLOCOCCUS LUDGUNESIS AND ENTEROCOCCUS FAECIUM DETECTED. CULTURE: STREPTOCOCCUS GALLOLYTICUS DETECTED. DATA REVIEW: PER VERIGENE ID SOFTWARE REQUIREMENTS SPECIFICATION (TOAST-SRS-1042), IN ORDER FOR AN ORGANISM TO BE DETECTED THE IC RATIO MUST BE GREATER THAN OR EQUAL TO -0.4 AND THE NC RATIO MUST BE GREATER THAN 0.85. REVIEW OF TEST CARTRIDGE 01864096 SHOWS STAPHYLOCOCCUS LUDGUNESIS DETECTED AT EXPOSURE 1200 (IC: -0.15 NC: 0.91) AND ENTEROCOCCUS FAECIUM WAS DETECTED AT EXPOSURE 1200 (IC: -034 AND NC: 0.86). PC1 WAS DETECTED AT EXPOSURE 24 (IC: 0.56 NC: 0.99) AND PC 2 WAS DETECTED AT EXPOSURE 150 WITH IC AND NC VALUES OF 0.5 AND 0.98 RESPECTIVELY. CAMERA IMAGES WERE NOT AVAILABLE. THIS WAS TESTED ON 6/4/2024 ON SP A4. CONSUMABLE REVIEW: TEST CARTRIDGE LOT: 031824018A, EXTRACTION TRAY LOT: 031124018B, UTILITY TRAY LOT: 030824018C. THERE ARE NO NCMRS ASSOCIATED WITH THE LOTS UTILIZED. THERE ARE 24 OTHER ERRONE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19657828 ↗
• MalfunctionJun 14, 2024No Apparent Adverse Event; No Apparent Adverse Event

  ON 5/15/2024 CUSTOMER (B)(6) REPORTED A DISCREPANT RESULT ON BC-GP ASSAY. VERIGENE DETECTED STAPHYLOCOCCUS LUGDUNENSIS, HOWEVER MALDI DETECTED STAPHYLOCOCCUS HOMINIS. VERIGENE: STAPHYLOCOCCUS LUDGUNESIS DETECTED. MALDI: STAPHYLOCOCCUS HOMINIS DETECTED. DATA REVIEW PER VERIGENE ID SOFTWARE REQUIREMENTS SPECIFICATION (TOAST-SRS-1042), IN ORDER FOR AN ORGANISM TO BE DETECTED THE IC RATIO MUST BE GREATER THAN OR EQUAL TO -0.4 AND THE NC RATIO MUST BE GREATER THAN 0.85. REVIEW OF TEST CARTRIDGE 01866515 SHOWS STAPHYLOCOCCUS LUDGUNESIS WAS DETECTED AT EXPOSURE 1200 (IC: -0.28 NC: 0.86) WITH NO OTHER ELEVATED SIGNALS. PCL WAS DETECTED AT EXPOSURE 24 (IC: 0.81 NC: 0.99) AND PC 2 WAS DETECTED AT EXPOSURE 150 WITH IC AND NC VALUES OF 0.46 AND 0.98 RESPECTIVELY. CAMERA IMAGES WERE CLEAR WITH NO IMPACT ON RESULTS. THIS WAS TESTED ON (B)(6) 2024 ON SP B2. CONSUMABLE REVIEW TEST CARTRIDGE LOT: 031824018A EXTRACTION TRAY LOT: 032524018B UTILITY TRAY LOT: LOT INFORMATION NOT AVAILABLE. THERE ARE NO NCMRS ASSOCIATED WITH THE LOTS UTILIZED. THERE ARE TEN OTHER ERRONEOUS RESULTS REPORTED FOR THE STAPHYLOCOCCUS LUDGUNESIS TARGET USING THE LOTS REPORTED. DUE TO THE AMOUNT OF COMPLAINTS, FURTHER INVESTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542601 ↗
• MalfunctionJun 14, 2024No Apparent Adverse Event; No Apparent Adverse Event

  ON 5/15/2024 CUSTOMER (B)(6) MEDICAL CENTER REPORTED A DISCREPANT RESULT ON BC­GP ASSAY. VERIGENE DETECTED STAPHYLOCOCCUS LUGDUNENSIS, HOWEVER MALDI DETECTED STAPHYLOCOCCUS HOMINIS. VERIGENE: STAPHYLOCOCCUS LUDGUNESIS DETECTED. MALDI: STAPHYLOCOCCUS HOMINIS DETECTED. DATA REVIEW. PER VERIGENE ID SOFTWARE REQUIREMENTS SPECIFICATION (TOAST-SRS-1042), IN ORDER FOR AN ORGANISM TO BE DETECTED THE IC RATIO MUST BE GREATER THAN OR EQUAL TO -0.4 AND THE NC RATIO MUST BE GREATER THAN 0.85. REVIEW OF TEST CARTRIDGE 01866301 SHOWS STAPHYLOCOCCUS SPECIES DETECTED AT EXPOSURE 24 (IC: 0.4 NC: 0.98) AND STAPHYLOCOCCUS LUDGUNESIS WAS DETECTED AT EXPOSURE 1200 (IC: -0.17 NC: 0.88) WITH NO OTHER ELEVATED SIGNALS. PC1 WAS DETECTED AT EXPOSURE 150 (IC: 0.22 NC: 0.97) AND PC 2 WAS DETECTED AT EXPOSURE 24 WITH IC AND NC VALUES OF 0.77 AND 0.99 RESPECTIVELY. CAMERA IMAGES WERE CLEAR BEARING NO IMPACT ON RESULTS. THIS WAS TESTED ON 5/6/2024 ON SP A3. CONSUMABLE REVIEW. TEST CARTRIDGE LOT: 031824018A EXTRACTION TRAY LOT: 0325240188. UTILITY TRAY LOT: LOT INFORMATION NOT AVAILABLE. THERE ARE NO NCMRS ASSOCIATED WITH THE LOTS UTILIZED. THERE ARE SEVEN OTHER ERRONEOUS RESULTS REPORTED FOR THE STAPHYLOCOCCUS L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542600 ↗
• MalfunctionJun 14, 2024No Apparent Adverse Event; No Apparent Adverse Event

  ON 5/15/2024 CUSTOMER PROVIDENCE REGIONAL MEDICAL CENTER EVERETT REPORTED A DISCREPANT RESULT ON BC-GP ASSAY. VERIGENE DETECTED STAPHYLOCOCCUS LUGDUNENSIS, HOWEVER REPEAT TESTING SHOWED NO TARGETS DETECTED. VERIGENE RUN 1: STAPHYLOCOCCUS LUDGUNESIS DETECTED. VERIGENE RUN 2: NO TARGETS DETECTED. DATA REVIEW PER VERIGENE ID SOFTWARE REQUIREMENTS SPECIFICATION (TOAST-SRS-1042), IN ORDER FOR AN ORGANISM TO BE DETECTED THE IC RATIO MUST BE GREATER THAN OR EQUAL TO -0.4 AND THE NC RATIO MUST BE GREATER THAN 0.85. REVIEW OFTEST CARTRIDGE 01866139 SHOWS STAPHYLOCOCCUS LUDGUNESIS WAS DETECTED AT EXPOSURE 1200 (IC: -0.28 NC: 0.86) WITH NO OTHER ELEVATED SIGNALS. PCL WAS DETECTED AT EXPOSURE 24 (IC: 0.81 NC: 0.99) AND PC 2 WAS DETECTED AT EXPOSURE 150 WITH IC AND NC VALUES OF 0.46 AND 0.98 RESPECTIVELY. CAMERA IMAGES WERE CLEAR WITH NO IMPACT ON RESULTS. THIS WAS TESTED ON 5/10/2024 ON SP B2. CONSUMABLE REVIEW TEST CARTRIDGE LOT: 031824018A EXTRACTION TRAY LOT: 032524018B. UTILITY TRAY LOT: LOT INFORMATION NOT AVAILABLE. THERE ARE NO NCMRS ASSOCIATED WITH THE LOTS UTILIZED. THERE ARE TEN OTHER ERRONEOUS RESULTS REPORTED FOR THE STAPHYLOCOCCUS LUDGUNESIS TARGET USING THE LOTS REPORTED. DUE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542599 ↗
• MalfunctionJun 14, 2024No Apparent Adverse Event; No Apparent Adverse Event

  ON 5/15/2024 CUSTOMER (B)(6)MEDICAL CENTER (B)(6) REPORTED A DISCREPANT RESULT ON BC-GP ASSAY. VERIGENE DETECTED STAPHYLOCOCCUS LUGDUNENSIS, HOWEVER REPEAT TESTING SHOWED STAPHYLOCOCCUS EPIDERMIDIS DETECTED. VERIGENE RUN 1: STAPHYLOCOCCUS LUDGUNESIS DETECTED. VERIGENE RUN 2: STAPHYLOCOCCUS EPIDERMIDIS DETECTED. DATA REVIEW: DATA HAS NOT BEEN PROVIDED BY THE CUSTOMER. CONSUMABLE REVIEW: TEST CARTRIDGE LOT: 031824018A EXTRACTION TRAY LOT: 032524018B UTILITY TRAY LOT: LOT INFORMATION NOT AVAILABLE THERE ARE NO NCMRS ASSOCIATED WITH THE LOTS UTILIZED. THERE ARE TEN OTHER ERRONEOUS RESULTS REPORTED FOR THE STAPHYLOCOCCUS LUDGUNESIS TARGET USING THE LOTS REPORTED. DUE TO THE AMOUNT OF COMPLAINTS, FURTHER INVESTIGATION OF TEST CARTRIDGE LOT 031824018A WILL BE DOCUMENTED IN ESCALATION CASE (B)(4). DEVICE REVIEW: DEVICE INFORMATION HAS NOT BEEN PROVIDED BY THE CUSTOMER. SITE PERFORMANCE: A 6 MONTH CUSTOMER SITE PERFORMANCE FOR NEGATIVE AGREEMENT OF STAPHYLOCOCCUS LUDGUNESIS TARGET WAS PERFORMED FROM NOV/2023 TO MAY/2024. THERE WAS A NEGATIVE AGREEMENT OF 99.0% (684 NOT DETECTED/691 EXPECTED NOT DETECTED). PER THE VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST PACKAGE INSERT (89-3000

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542598 ↗
• MalfunctionJun 14, 2024No Apparent Adverse Event; No Apparent Adverse Event

  ON 5/15/2024 CUSTOMER (B)(6) MEDICAL CENTER REPORTED A DISCREPANT RESULT ON BC-GP ASSAY. VERIGENE DETECTED STAPHYLOCOCCUS LUGDUNENSIS, HOWEVER REPEAT TESTING SHOWED STREPTOCOCCUS AGALACTIAE DETECTED. VERIGENE RUN 1: STAPHYLOCOCCUS LUDGUNESIS DETECTED. VERIGENE RUN 2: STREPTOCOCCUS AGALACTIAE DETECTED. DATA REVIEW. PER VERIGENE ID SOFTWARE REQUIREMENTS SPECIFICATION (TOAST-SRS-1042), IN ORDER FOR AN ORGANISM TO BE DETECTED THE IC RATIO MUST BE GREATER THAN OR EQUAL TO -0.4 AND THE NC RATIO MUST BE GREATER THAN 0.85. REVIEW OFTEST CARTRIDGE 01866676 SHOWS STAPHYLOCOCCUS LUDGUNESIS WAS DETECTED AT EXPOSURE 150 (IC: -0.3 NC: 0.88) WITH NO OTHER ELEVATED SIGNALS. PCL WAS DETECTED AT EXPOSURE 24 (IC: 0.29 NC: 0.96) AND PC 2 WAS DETECTED AT EXPOSURE 24 WITH IC AND NC VALUES OF 0.25 AND 0.96 RESPECTIVELY. CAMERA IMAGES WERE CLEAR WITH NO IMPACT ON RESULTS. THIS WAS TESTED ON 5/6/2024 ON SP A2. CONSUMABLE REVIEW TEST CARTRIDGE LOT: 031824018A EXTRACTION TRAY LOT: 032524018B UTILITY TRAY LOT: LOT INFORMATION NOT AVAILABLE THERE ARE NO NCMRS ASSOCIATED WITH THE LOTS UTILIZED. THERE ARE TEN OTHER ERRONEOUS RESULTS REPORTED FOR THE STAPHYLOCOCCUS LUDGUNESIS TARGET USING THE LOTS REPORTED. DUE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542597 ↗
• MalfunctionJun 14, 2024No Apparent Adverse Event; No Apparent Adverse Event

  ON 5/15/2024 CUSTOMER (B)(6) MEDICAL CENTER (B)(6) REPORTED A DISCREPANT RESULT ON BC-GP ASSAY. VERIGENE DETECTED STAPHYLOCOCCUS LUGDUNENSIS, HOWEVER MALDI DETECTED PORPHYROMONAS GINGIVALIS AND CUTIBACTERIUM. VERIGENE: STAPHYLOCOCCUS LUDGUNESIS DETECTED. MALDI: PORPHYROMONAS GINGIVALIS AND CUTIBACTERIUM DETECTED. DATA REVIEW: PER VERIGENE ID SOFTWARE REQUIREMENTS SPECIFICATION (TOAST-SRS-1042), IN ORDER FOR AN ORGANISM TO BE DETECTED THE IC RATIO MUST BE GREATER THAN OR EQUAL TO -0.4 AND THE NC RATIO MUST BE GREATER THAN 0.85. REVIEW OFTEST CARTRIDGE 01866289 SHOWS STAPHYLOCOCCUS LUDGUNESIS WAS DETECTED AT EXPOSURE 300 (IC: -0.36 NC: 0.88) WITH NO OTHER ELEVATED SIGNALS. PCL WAS DETECTED AT EXPOSURE 24 (IC: 0.8 NC: 0.99) AND PC 2 WAS DETECTED AT EXPOSURE 24 WITH IC AND NC VALUES OF 0.89 AND 0.99 RESPECTIVELY. CAMERA IMAGES WERE CLEAR BEARING NO IMPACT ON RESULTS. THIS WAS TESTED ON 5/3/2024 ON SP AL. CONSUMABLE REVIEW: TEST CARTRIDGE LOT: 031824018A EXTRACTION TRAY LOT: 032524018B UTILITY TRAY LOT: LOT INFORMATION NOT AVAILABLE. THERE ARE NO NCMRS ASSOCIATED WITH THE LOTS UTILIZED. THERE ARE TEN OTHER ERRONEOUS RESULTS REPORTED FOR THE STAPHYLOCOCCUS LUDGUNESIS TARGET USING THE LOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19538011 ↗
• MalfunctionJun 7, 2024No Apparent Adverse Event; No Apparent Adverse Event

  ON 5/13/2024 CUSTOMER (B)(6) MEDICAL CENTER REPORTED A DISCREPANT RESULT ON BC-GP ASSAY. VERIGENE DETECTED STAPHYLOCOCCUS LUGDUNENSIS, ENTEROCOCCUS FAECIUM, AND MICROCOCCUS HOWEVER CULTURE SHOWED NO TARGETS DETECTED. VERIGENE RUN 1: STAPHYLOCOCCUS LUDGUNESIS AND ENTEROCOCCUS FAECIUM DETECTED CULTURE: NO TARGETS DETECTED. DATA REVIEW: PER VERIGENE ID SOFTWARE REQUIREMENTS SPECIFICATION ((B)(4)), IN ORDER FOR AN ORGANISM TO BE DETECTED THE IC RATIO MUST BE GREATER THAN OR EQUAL TO -0.4 AND THE NC RATIO MUST BE GREATER THAN 0.85. REVIEW OF TEST CARTRIDGE (B)(6) SHOWS STAPHYLOCOCCUS LUDGUNESIS DETECTED AT EXPOSURE 1200MS (IC: -0.22 NC: 0.91) AND ENTEROCOCCUS FAECIUM DETECTED AT EXPOSURE 1200MS. PC1 WAS DETECTED AT EXPOSURE 24MS (IC: 0.66 NC: 0.99) AND PC 2 WAS DETECTED AT EXPOSURE 150 WITH IC AND NC VALUES OF 0.23 AND 0.98 RESPECTIVELY. CAMERA IMAGES WERE CLEAR WITH MINOR BACKGROUND AND NO IMPACT ON RESULTS. THIS WAS TESTED ON (B)(6) 2024 ON SP A1. CONSUMABLE REVIEW: TEST CARTRIDGE LOT: 031824018A. EXTRACTION TRAY LOT: 031124018B. UTILITY TRAY LOT: 030824018C. THERE ARE NO NCMRS ASSOCIATED WITH THE LOTS UTILIZED. THERE ARE 22 OTHER ERRONEOUS RESULTS REPORTED FOR THE STAPHYLOCOCCUS LUDG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19492332 ↗
• MalfunctionJun 7, 2024No Apparent Adverse Event; No Apparent Adverse Event

  ON 5/13/2024 CUSTOMER (B)(6) MEDICAL CENTER REPORTED A DISCREPANT RESULT ON BC-GP ASSAY. VERIGENE DETECTED STAPHYLOCOCCUS SPECIES AND STAPHYLOCOCCUS LUGDUNENSIS HOWEVER CULTURE SHOWED NO TARGETS DETECTED. VERIGENE RUN 1: STAPHYLOCOCCUS SPECIES AND STAPHYLOCOCCUS LUDGUNESIS DETECTED CULTURE: NO TARGETS DETECTED. DATA REVIEW: PER VERIGENE ID SOFTWARE REQUIREMENTS SPECIFICATION ((B)(4)), IN ORDER FOR AN ORGANISM TO BE DETECTED THE IC RATIO MUST BE GREATER THAN OR EQUAL TO -0.4 AND THE NC RATIO MUST BE GREATER THAN 0.85. REVIEW OF TEST CARTRIDGE (B)(6) SHOWS STAPHYLOCOCCUS SPECIES DETECTED AT EXPOSURE 24MS (IC: 0.43 NC: 0.99) AND STAPHYLOCOCCUS LUDGUNESIS DETECTED AT EXPOSURE 1500MS (IC: -0.32 NC: 0.93). PC1 WAS DETECTED AT EXPOSURE 24MS (IC: 0.4 NC: 0.99) AND PC 2 WAS DETECTED AT EXPOSURE 150MS WITH IC AND NC VALUES OF 0.2 AND 0.99 RESPECTIVELY. CAMERA IMAGES WERE CLEAR WITH MINOR BACKGROUND AND NO IMPACT ON RESULTS. THIS WAS TESTED ON (B)(6) 2024 ON SP A1. CONSUMABLE REVIEW: TEST CARTRIDGE LOT: 031824018A. EXTRACTION TRAY LOT: 031124018B. UTILITY TRAY LOT: 030824018C. THERE ARE NO NCMRS ASSOCIATED WITH THE LOTS UTILIZED. THERE ARE 22 OTHER ERRONEOUS RESULTS REPORTED FOR THE STAPHYLOC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19489685 ↗
• MalfunctionJun 6, 2024No Apparent Adverse Event; No Apparent Adverse Event

  ON 5/13/2024 CUSTOMER (B)(6) MEDICAL CENTER REPORTED A DISCREPANT RESULT ON BC-GP ASSAY. VERIGENE DETECTED STAPHYLOCOCCUS LUGDUNENSIS AND ENTEROCOCCUS FAECIUM HOWEVER CULTURE SHOWED NO TARGETS DETECTED. VERIGENE RUN 1: STAPHYLOCOCCUS LUDGUNESIS AND ENTEROCOCCUS FAECIUM DETECTED CULTURE: NO TARGETS DETECTED. DATA REVIEW: PER VERIGENE ID SOFTWARE REQUIREMENTS SPECIFICATION (TOAST-SRS-1042), IN ORDER FOR AN ORGANISM TO BE DETECTED THE IC RATIO MUST BE GREATER THAN OR EQUAL TO -0.4 AND THE NC RATIO MUST BE GREATER THAN 0.85. REVIEW OF TEST CARTRIDGE 01864029 SHOWS STAPHYLOCOCCUS LUDGUNESIS DETECTED AT EXPOSURE 1200MS (IC: -0.38 NC: 0.87) AND ENTEROCOCCUS FAECIUM DETECTED AT EXPOSURE 1500MS (IC: -0.4 NC: 087). PC1 WAS DETECTED AT EXPOSURE 24MS (IC: 0.61 NC: 1) AND PC 2 WAS DETECTED AT EXPOSURE 150MS WITH IC AND NC VALUES OF 0.08 AND 0.99 RESPECTIVELY. CAMERA IMAGES WERE CLEAR WITH MINOR BACKGROUND AND NO IMPACT ON TEST RESULTS. THIS WAS TESTED ON (B)(6) 2024 ON SP B3. CONSUMABLE REVIEW: TEST CARTRIDGE LOT: 031824018A. EXTRACTION TRAY LOT: 031124018B. UTILITY TRAY LOT: 030824018C. THERE ARE NO NCMRS ASSOCIATED WITH THE LOTS UTILIZED. THERE ARE 22 OTHER ERRONEOUS RESULTS REPORTED FOR THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477876 ↗
• DeathOct 21, 2021False Positive Result

  CUSTOMER REPORTED A (B)(6) WITH VERIGENE BC-GP ASSAY FOR A PATIENT SAMPLE. THE PATIENT WAS PLACED ON (B)(6) AFTER INITIAL VERIGENE RUN REPORTED (B)(6). THE CUSTOMER WAS TAKEN OFF THE (B)(6) ONCE THE CONFIRMATION TESTING OF NO (B)(6) WERE REPORTED. THE CUSTOMER COULD NOT CONFIRM IF THE PATIENT WAS SWITCHED TO A DIFFERENT TREATMENT OR TAKEN OFF ALL MEDICATIONS. THE CUSTOMER VERIFIED PATIENT DEATH AS (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 12674550 ↗
• MalfunctionNov 20, 2020False Positive Result

  CUSTOMER REPORTING FALSE POSITIVE FOR S.AUREUS FOR VERIGENE BC-GP ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10874890 ↗