The Recall Desk
HighFDA (Devices)·Z-2008-2021·Announced 2021-07-14

Verigene Gram Negative Blood Culture Test Recalled for Potential False-Negative Results

Luminex Corporation is recalling 17,110 units of the Verigene Gram Negative Blood Culture test (Model 20-006-021) due to potential false-negative results that may fail to detect Gram-negative bacterial infections.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a diagnostic blood culture test with potential for false-negative results, which could delay or prevent detection of bacterial infections. No illnesses or injuries have been reported, but the risk of missed diagnoses in a critical diagnostic application justifies High severity.

Plain-English summary

Luminex Corporation is recalling the Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number 20-006-021 due to the potential for false-negative results. This diagnostic test is used to identify Gram-negative bacteria in blood culture samples.

The test may produce false-negative results, meaning it could fail to detect Gram-negative infections when they are present in a blood sample. This could result in delayed diagnosis or failure to detect bacterial infections that require treatment.

Approximately 17,110 units were distributed worldwide, including throughout the United States and in Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and the United Kingdom. Affected lot codes include: 030320021B, 031220021A, 032720021B, 040820021A, 041020021A, 041720021A, 042220021A, 042920021A, 050520021A, 051220021A, 051920021A, 053020021A, 060520021A, 061220021A, 061720021A, 070120021A, 072420021A, 081820021B, and 082620021A.

The recalled product

Product
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
Manufacturer
Luminex Corporation
Category
Medical Device — Diagnostic Test
Hazard
  • false-negative-result
  • misdiagnosis

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • 030320021B
  • 031220021A
  • 032720021B
  • 040820021A
  • 041020021A
  • 041720021A
  • 042220021A
  • 042920021A
  • 050520021A
  • 051220021A
  • 051920021A
  • 053020021A
  • 060520021A
  • 061220021A
  • 061720021A
  • 070120021A
  • 072420021A
  • 081820021B
  • and 082620021A

Distribution

Distributed nationwide across the United States.

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