Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge 20-006-021 (UDI 00857573006140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00857573006140), received between Jul 19, 2019 and Nov 22, 2019 — classified as 2 deaths.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

8 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.

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.

• DeathNov 22, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem; Adverse Event Without Identified Device or Use Problem

  VERIGENE PROCESSOR SP, SERIAL NUMBER: (B)(6), WAS RETURNED TO THE LUMINEX VRF FOR INVESTIGATION ON NOVEMBER 8, 2019. UPON INVESTIGATION INTO THE VERIGENE SYSTEM, IT WAS FOUND THAT A HARDWARE FAILURE CONTRIBUTED TO THE "ALL TARGETS NOT DETECTED", FALSE NEGATIVE RESULT. AS AN ELEMENT OF THE INVESTIGATION PERFORMED UNDER WORK ORDER: (B)(4), THE SYSTEM NAP LOG FOR VERIGENE PROCESSOR SP (SERIAL NUMBER: (B)(6) WAS REVIEWED HISTORICALLY, WITH A BEGINNING DATE OF (B)(6) 2019. DURING THE COURSE OF THIS INVESTIGATION, IT WAS DETERMINED THAT AN UNEXPECTED VERIGENE SYSTEM POWER LOSS AND "REBOOT" OCCURRED ON (B)(6) 2019 WHILE PERFORMING SYSTEMATIC SONICATION STEPS IN THE MIDST OF AN ASSAY RUN. PRIOR TO THIS "REBOOT" EVENT, THE VERIGENE SYSTEM WAS RECORDING AN APPROPRIATE LEVEL OF UTILIZED CURRENT FOR THE SONICATION HORNS BUT FOLLOWING THE EVENT, SUBSEQUENT ASSAY RUNS DID NOT HAVE ADEQUATE SONICATION CURRENT LEVELS (CURRENT WAS RECORDED IN THE NAP LOGS AS 0.000A). RECORDED SONICATION CURRENT OF 0.000A IS AN INDICATION OF A SONICATION BOARD (PCBA) FAILURE. SUBSEQUENT INVESTIGATION ON THE IMPACT OF A SONICATION BOARD FAILURE UPON PERFORMED BC-GN ASSAYS INDICATED THAT BC-GN ASSAY RESULTS WOULD BE N

  Patient problems: Bacterial Infection; Death; Sepsis

  MAUDE report 9363438 ↗
• DeathJul 19, 2019Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 SAMPLE (B)(6) WAS PROCESSED USING THE CARTRIDGE ID (B)(6) VERIGENE GRAM-NEGATIVE BLOOD CULTURE TEST (BC-GN) ON THE VERIGENE SYSTEM. VERIGENE RESULT WAS PSEUDOMONAS AERUGINOSA DETECTED AND REPORTED OUT TO A PHYSICIAN ON (B)(6) 2019. PATIENT SAMPLE WAS RUN ON VITEK, AND THE VITEK RESULT WAS REPORTED ON (B)(6) 2019 AS P.AERUGINOSA IDENTIFIED, CEFAZOLIN AND MEROPENEM RESISTANT. THE HOSPITAL FACILITY NOTIFIED LUMINEX (NANOSPHERE) OF THE DISCREPANCY BETWEEN THE BC-GN AND VITEK RESULTS ON (B)(6) 2019 AND PROVIDED DETAILS OF THE TREATMENT. THE PATIENT WAS TREATED WITH MEROPENEM AND TOBRAMYCIN FOR 48 HOURS FOLLOWING THE VERIGENE RESULT. FOLLOWING THE VITEK RESULT, TREATMENT WAS ALTERED AND MEROPENEM WAS DISCONTINUED ON (B)(6) 2019. CIPROFLOXACIN AND AVYCAZ WERE ADDED TO TREATMENT ON (B)(6 2019. ON (B)(6) 2019, THE PATIENT EXPIRED FROM CARDIAC ARREST.

  Patient problems: Cardiac Arrest; Death; Unspecified Infection

  MAUDE report 8809480 ↗

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-1903-2025 · Apr 16, 2025 · Completed
  VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
• 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