Z-1903-2025 Class II
FDA device recall Z-1903-2025 was initiated by Luminex Corporation on April 16, 2025 and is designated Class II. 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. Affected quantity: 89 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 11, 2025
- Initiation Date
- April 16, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89 units
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.
Distribution Pattern
US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.
Code Information
UDI/DI 00840487101599, Lot Number 022525021A, exp. 08/26/2025