Recall Z-2094-2017— Luminex Corporation

Name: FDA recall Z-2094-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-19

Class II · Terminated

Class II FDA medical device recall by Luminex Corporation, initiated 2017-04-19, terminated 2017-10-20. It names 3 FDA 510(k) clearances: K162772, K160517, K151917. Product: ARIES System and ARIES M1 System. Reason: The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems populates patient sample IDs with a previously scanned sample ID when entering orders into an ARIES instrument..

Recalling firm: Luminex Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-04-19
Terminated: 2017-10-20
Firm location: Austin, TX, United States

510(k) clearances named in this recall

3 on FDA's record

K162772 — ARIES GBS AssayLuminex Corporation·cleared 2016-12-23
K160517 — ARIES SystemLuminex Corporation·cleared 2016-04-12
K151917 — ARIES SystemLuminex Corporation·cleared 2015-10-06

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

ARIES System and ARIES M1 System

Reason for recall

The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems populates patient sample IDs with a previously scanned sample ID when entering orders into an ARIES instrument.

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