FDA Medical devices recall ·
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test recall
- Recall number
- Z-1903-2025
- Date
- (initiated April 16, 2025)
- Company / brand
- Luminex Corporation
4088 Commercial Ave, Northbrook, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Completed
- Units affected
- 89 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 00840487101599, Lot Number 022525021A, exp. 08/26/2025
Distribution
US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.
States: Alabama Arizona California Connecticut Georgia Maryland Minnesota New Jersey South Carolina Texas Virginia Vermont Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1903-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.