Recall Z-0445-2019— Luminex Corporation

Name: FDA recall Z-0445-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-14

Class II · Terminated

Class II FDA medical device recall by Luminex Corporation, initiated 2018-09-14, terminated 2021-04-28. It names one FDA 510(k) clearance: K122514. Product: VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.. Reason: Potential to lead to a false negative results..

Recalling firm: Luminex Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-09-14
Terminated: 2021-04-28
Firm location: Austin, TX, 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 Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.

Reason for recall

Potential to lead to a false negative results.

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