Recall Z-1109-2022— Luminex Corporation

Name: FDA recall Z-1109-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-15

Class II · Ongoing

Class II FDA medical device recall by Luminex Corporation, initiated 2022-02-15. It names one FDA 510(k) clearance: K132843. Product: VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021. Reason: Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot..

Recalling firm: Luminex Corporation
Classification: Class II
Status: Ongoing
Initiated: 2022-02-15
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 Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021

Reason for recall

Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.

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