The Recall Desk
HighFDA (Devices)·Z-1335-2022·Announced 2022-07-13

VERIGENE Enteric Pathogens Test may yield false negative results

Luminex Corporation is recalling VERIGENE Enteric Pathogens tests worldwide due to potential false negative results caused by hydrophobic characteristics of the sampling swab. The defect could lead to missed detection of infections in stool specimens.

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: FDA Class II medical device with potential for false negative results in diagnostic pathogen detection. No reported illnesses or injuries have been documented. Per the rubric, risk-of-harm diagnostic products where injury has not yet been reported score 3 (High).

Plain-English summary

Luminex Corporation is recalling the VERIGENE Enteric Pathogens Nucleic Acid Test (Part No. 30-002-23) worldwide. The recalled kits include VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT. Approximately 5,601 units have been distributed to medical laboratories and diagnostic facilities in the United States and internationally.

The recall is issued due to a potential for false negative results caused by hydrophobic characteristics of the sampling swab used with the test kits. This defect could result in a specimen failing to be properly collected or processed, leading to false negative test results that would miss the presence of enteric pathogens in patient samples.

Affected facilities should review their use of the recalled lot numbers and consider alternative diagnostic methods for testing stool specimens for enteric pathogens. Healthcare providers should be aware of the potential testing limitation when interpreting results from affected kits and consider retesting if clinically indicated.

Patients and healthcare providers who believe they have been affected should contact Luminex Corporation or consult with their laboratory provider for guidance on proper handling of affected test kits and appropriate follow-up testing.

The recalled product

Product
VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
Manufacturer
Luminex Corporation
Category
Medical Device — Diagnostic Test / Stool Analysis
Hazard
  • false-negative-results
  • swab-defect

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 (20)

  • UDI 00840487101568 Luminex Lot Number 030121023A
  • FLOQSwab Lot Number: 2100856
  • Luminex Lot Number 030221023D
  • Luminex Lot Number 030221023E
  • Luminex Lot Number 030221023F
  • Luminex Lot Number 030821023A
  • Luminex Lot Number 030921023D
  • Luminex Lot Number 031021023E
  • Luminex Lot Number 031621023D
  • Luminex Lot Number 031721023D
  • Luminex Lot Number 032221023A
  • FLOQSwab Lot Number: 2032870
  • Luminex Lot Number 032421023E
  • Luminex Lot Number 032521023E
  • Luminex Lot Number 033021023E
  • Luminex Lot Number 041421023F
  • Luminex Lot Number 050521023H
  • Luminex Lot Number 050621023C
  • Luminex Lot Number 051221023E
  • Luminex Lot Number 051221023F

Distribution

Distributed nationwide across the United States.

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