Recall Z-2451-2021— Luminex Corporation

Name: FDA recall Z-2451-2021
Creator: U.S. Food and Drug Administration
Published: 2021-08-03

Class II · Ongoing

Class II FDA medical device recall by Luminex Corporation, initiated 2021-08-03. It names one FDA 510(k) clearance: K140083. Product: Verigene EP Amplification Reagent Kit Test. Reason: There is potential for false positive results..

Recalling firm: Luminex Corporation
Classification: Class II
Status: Ongoing
Initiated: 2021-08-03
Firm location: Northbrook, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K140083 — VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)Nanosphere, Inc.·cleared 2014-06-20

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 EP Amplification Reagent Kit Test

Reason for recall

There is potential for false positive results.

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