Recall Z-2533-2024— Luminex Corporation

Name: FDA recall Z-2533-2024
Creator: U.S. Food and Drug Administration
Published: 2024-06-20

Class II · Ongoing

Class II FDA medical device recall by Luminex Corporation, initiated 2024-06-20. It names one FDA 510(k) clearance: K122514. Product: Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test. Reason: Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets..

Recalling firm: Luminex Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-06-20
Firm location: Northbrook, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TESTNanosphere, Inc.·cleared 2012-09-19

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 Positive Blood Culture (BC-GP) Nucleic Acid Test

Reason for recall

Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.

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