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
Reported: June 11, 2025 Initiated: April 16, 2025 #Z-1903-2025
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- Luminex Corporation
- Units Affected
- 89 units
- Distribution
- US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.
- Location
- Northbrook, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Luminex Corporation. Units affected: 89 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 11, 2025. Severity: Moderate. Recall number: Z-1903-2025.
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