Gram-Negative Blood Culture (BC-GN) Utility Tray 20-011-021Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840487101698), received between May 10, 2022 and May 10, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2022Manufacturing, Packaging or Shipping Problem

  (B)(6) 2021 CUSTOMER REPORTING NO CALL INT CTL ON QC AND PATIENT SAMPLES WHILE UTILIZING THE VERIGENE BC-GN ASSAY. TS REQUESTED DATA AND SENT A RETURN LABEL TO THE CUSTOMER AND WILL SEND ANOTHER BLUE USB TO THE CUSTOMER AS WELL. PER SO 280785 THE CUSTOMER ORDERED 4 KITS OF VERIGENE BC-GN ASSAY WITH ET LOT 101321021B. TS SWITCHED RISK ANALYSIS QUESTION 2, "DID THE DEVICE MALFUNCTION, FAIL TO MEET ANY LABELED CLAIM, OR OTHERWISE FAIL TO PERFORM AS DESCRIBED IN ITS INTENDED USE?" TO A YES. 12.21.21 TS REQUESTED APPROVAL TO SEND THE CUSTOMER 4 KITS OF THE VERIGENE BC-GN ASSAY. 12.22.21 TS RECEIVED APPROVAL TO SEND THE CUSTOMER 4 VERIGENE BC-GN KITS TO THE CUSTOMER DUE TO THE NO CALL INT CTL (SEE EMAIL). TS PLACED THE ORDER TO SEND THESE KITS TO THE CUSTOMER. 12.29.21 PER FEDEX TRACKING (B)(4), SHIPMENT ARRIVED AT CUSTOMER SITE AND PACKAGES WERE SIGNED FOR BY (B)(6). CUSTOMER CONFIRMED RECEIPT AND NOTED 2 BOXES WERE MISSING FROM SHIPMENT. 01.03.22 CUSTOMER REPORTED THAT THE REMAINING BOXES ARRIVED 12.30.31 WITH NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14349797 ↗

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