Recall Z-1903-2025— Luminex Corporation

Name: FDA recall Z-1903-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-16

Class II · Completed

Class II FDA medical device recall by Luminex Corporation, initiated 2025-04-16. It names one FDA 510(k) clearance: K132843. 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. Reason: 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..

Recalling firm: Luminex Corporation
Classification: Class II
Status: Completed
Initiated: 2025-04-16
Firm location: Northbrook, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K132843 — VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)Nanosphere, Inc.·cleared 2014-01-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.