Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge 20-006-021 (UDI 00840487101599)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00840487101599), received between Dec 2, 2020 and Apr 4, 2025 — classified as 1 death, 14 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

1 FDA recall record name this device's identifier.

7 other recalls cover devices cleared under the same FDA submission (K132843); they may or may not involve this specific model.

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. Apr 16, 2025Class IICompleted

   It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.

   Z-1903-2025 · 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.

• MalfunctionApr 4, 2025False Negative Result; False Negative Result

  NC-08933 WAS OPENED AFTER NO CALL INT- CTL 1 RESULTS (HYBRIDIZATION CONTROL FAILURES), 2 FALSE NEGATIVE FALSE NEGATIVE RESULTS FOR OXA (ACINETOBACTER BAUMAUNII), AND 1 FALSE NEGATIVE FOR CTX-M (KLEBSIELLA PNEUMONIAE) OCCURRED DURING QC TESTING. THE NC INVESTIGATION CONCLUDED THAT THE INVALID AND FALSE NEGATIVE CALLS WERE CAUSED BY THE RELEASED VERIGENE BC-GN (PN: 20-006-021) TEST CARTRIDGE LOT: 022525021A (MICROPLATE LOT: G70-12563856 DECK A). DURING THE PRODUCTION OF VERIGENE BC-GN TEST CARTRIDGE LOT: 022525021A, MULTIPLE MICROPLATE DECK LOTS (SUBSTRATES ARRAYED WITH BLOOD CULTURE GRAM NEGATIVE APPLICATION CAPTURE OLIGONUCLEOTIDES) ARE USED IN THE ARRAYING PROCESS. MICROPLATE LOT: G70-12563856 DECK A WAS USED IN 120 TEST CARTRIDGES FROM LOT: 022525021A. 89 OF THOSE TEST CARTRIDGES WERE DISTRIBUTED TO CUSTOMER SITES FROM 3/3/2025 TO 3/6/2025. AN ANALYSIS WAS CONDUCTED ON THE INITIAL QSR TESTING FOR ALL THE EXTRACTION AND UTILITY TRAY LOTS THAT WERE TESTED WITH TEST CARTRIDGE LOT: 022525021A. THE SIGNAL INTENSITY WAS EVALUATED ACROSS ALL REPLICATES AT EACH EXPOSURE TO DETERMINE WHETHER THE HYBRIDIZATION CONTROL WAS DETECTED AND TO IDENTIFY ANY INSTANCES OF SIGNAL SUPPRESSION. THE AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774137 ↗
• MalfunctionJan 17, 2023Defective Component; Defective Component

  CUSTOMER REPORTED NO CALLS WITH VERIGENE BC-GN ASSAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16188804 ↗
• MalfunctionJan 13, 2022Insufficient Device Problem Information

  (B)(6) 2021: CUSTOMER CALLED IN TO REPORT NO CALL INT CTL WHILE USING THE BC-GN ASSAY. THERE WAS A DEVICE MALFUNCTION, ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE THE INFORMATION WILL BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13254145 ↗
• MalfunctionDec 22, 2021Defective Device

  ON (B)(6) 2021: CUSTOMER REPORTING NO CALL INT CTL ON QC SAMPLES WHILE UTILIZING THE VERIGENE BC-GN ASSAY. THERE WAS A DEVICE MALFUNCTION, ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE THE INFORMATION WILL BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13061184 ↗
• MalfunctionDec 22, 2021Output Problem

  (B)(6) 2021: CUSTOMER CONTACTED TS TO REPORT 15 NO CALL - INT CTL RESULTS WHILE TESTING ON THE VERIGENE BC-GN ASSAY. THERE WAS A DEVICE MALFUNCTION, ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE THE INFORMATION WILL BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13061180 ↗
• MalfunctionDec 22, 2021Output Problem

  ON (B)(6) 2021: CUSTOMER REPORTED NO CALL INT CTL RESULTS WHILE UTILIZING THE VERIGENE BC-GN ASSAY. THERE WAS A DEVICE MALFUNCTION, ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE THE INFORMATION WILL BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13061178 ↗
• MalfunctionDec 17, 2021Defective Device

  ON (B)(6) 2021: CUSTOMER REPORTED NO CALL INT CTL ON PATIENT AND QC SAMPLES WHILE UTILIZING THE VERIGENE BC-GN ASSAY. THERE WAS A DEVICE MALFUNCTION, ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE THE INFORMATION WILL BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13028663 ↗
• MalfunctionDec 17, 2021Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021: CUSTOMER CALLED IN TO REPORT MULTIPLE NO CALL INT CTL RESULTS WHILE USING THE BC-GN ASSAY. THERE WAS A DEVICE MALFUNCTION, ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE THE INFORMATION WILL BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13027769 ↗
• MalfunctionDec 1, 2021Output Problem

  A CUSTOMER HAD REPORTED 'NO CALL' INTERNAL CONTROL ERROR ON THE VERIGENE BC-GN ASSAY. THE 'NO CALL' ERROR HAD OCCURRED DURING QUALITY CONTROL (QC) TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT HAD OCCURRED. THERE WAS A DEVICE MALFUNCTION, ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE THE INFORMATION WILL BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12911560 ↗
• MalfunctionDec 1, 2021Incorrect, Inadequate or Imprecise Result or Readings

  (B)(6) 2021: CUSTOMER REPORTED MULTIPLE NO CALL - INT CTL RESULTS WHILE TESTING ON PATIENT AND QC SAMPLES ON THE VERIGENE BC-GN ASSAY. CUSTOMER STATED THAT THE NO CALLS OCCURRED ACROSS MULTIPLE SP'S AND THEY HAVE SINCE SWITCHED TO A NEW LOT OF TEST CARTRIDGES AND ARE NO LONGER EXPERIENCING ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908974 ↗
• MalfunctionNov 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER HAD REPORTED 'NO CALL' INTERNAL CONTROL ERROR ON THE VERIGENE BC-GN ASSAY. THE 'NO CALL' ERROR HAD OCCURRED DURING QUALITY CONTROL (QC) TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT HAD OCCURRED. THERE WAS A DEVICE MALFUNCTION, ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE THE INFORMATION WILL BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869294 ↗
• MalfunctionNov 22, 2021Display or Visual Feedback Problem

  A CUSTOMER HAD REPORTED 'NO CALL' INTERNAL CONTROL ERROR ON THREE (3) CARTRIDGES ON THE VERIGENE BC-GN ASSAY. THE 'NO CALL' ERROR HAD OCCURRED DURING QUALITY CONTROL (QC) TESTING, FOR NEGATIVE AND POSITIVE CONTROLS. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT HAD OCCURRED. THERE WAS A DEVICE MALFUNCTION, ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE THE INFORMATION WILL BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12856556 ↗
• MalfunctionDec 21, 2020False Negative Result; False Negative Result

  A CUSTOMER HAD REPORTED A FALSE NEGATIVE CTX-M MARKER WHILE UTILIZING VERIGENE BC-GN ASSAY, A CHANGE IN THERAPY RESULTED BASED ON THE VERIGENE RESULTS. NO PATIENT HARM BASED ON THE CHANGE IN THERAPY WAS REPORTED. THE VERIGENE BC-GN CONSUMABLE WAS NOT AVAILABLE. VERIGENE READER AND PROCESSOR USED WITH THE CONSUMABLE, WERE EVALUATED ON 05 NOV 2020 FOR A MALFUNCTION, THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. THIS INVESTIGATION IS ONGOING, IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11046564 ↗
• DeathDec 21, 2020Failure to Fold; Failure to Fold

  A CUSTOMER HAD REPORTED A FALSE NEGATIVE CTX-M MARKER WHILE UTILIZING VERIGENE BC-GN ASSAY ON (B)(6) 2020. ON (B)(6) 2020, AFTER FURTHER INVESTIGATION IT WAS DETERMINED THAT THE DEVICE WAS PERFORMING PER PERFORMANCE SPECIFICATION PER THE PACKAGE INSERT, AND THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

  Patient problems: Cardiogenic Shock; Death; Septic Shock

  MAUDE report 11046263 ↗
• MalfunctionDec 2, 2020False Positive Result; False Positive Result

  A CUSTOMER HAD REPORTED A FALSE POSITIVE OXA AND KPC MARKER WHILE UTILIZING VERIGENE BC-GN ASSAY. THE CUSTOMER HAD ALTERED THE THERAPY BASED ON THE VERIGNE RESULTS, THERE WAS NO ADVERSE EVENT OR HARM REPORTED WITH THIS EVENT. AFTER FURTHER INVESTIGATION OF THE EVENT AND PRODUCT LOT NUMBER, IT WAS DETERMINED THAT THE DEVICE HAD MALFUNCTIONED AND PROVIDED FALSE POSITIVE RESULTS DUE TO NON-SPECIFIC BINDING. THIS WAS PREVIOUSLY IDENTIFIED AS A MALFUNCTION THAT WAS COMMUNICATED TO CUSTOMERS THROUGH A CUSTOMER ADVISORY NOTICE (CAN) PER RECALL 3006028115-10/9/2020-001-C (SUBMITTED TO FDA ON 09 OCTOBER 2020). AT THE TIME OF THE EVENT, IT WAS IDENTIFIED THAT THE CUSTOMER HAD NOT YET INSTALLED THE LATEST SOFTWARE PER THE CAN INSTRUCTION. THE CUSTOMER'S SOFTWARE WAS UPDATED ON 19 NOVEMBER 2020 TO MITIGATE ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY OR DEATH IDENTIFIED AS PART OF THIS EVENT. IN A CASE WHERE UPDATED INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: Insufficient Information

  MAUDE report 10931580 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132843. One submission often covers many models, so check the product and lot details in each record.

• Z-1109-2022 · Feb 15, 2022 · Open, Classified
  VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
• Z-2008-2021 · Oct 30, 2020 · Open, Classified
  Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
• Z-2776-2020 · Jun 15, 2020 · Terminated
  Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and
• Z-2236-2014 · Jul 9, 2014 · Terminated
  Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, includ
• Z-2170-2014 · Apr 17, 2014 · Terminated
  Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the
• Z-2681-2014 · Oct 10, 2013 · Terminated
  The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for
• Z-2736-2014 · Jun 17, 2013 · Terminated
  Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identific