Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

ARIES System and ARIES M1 System

FDA Recall Z-2094-2017 · Posted None

Recalling FirmLuminex Corporation
Recall StatusTerminated
Product CodeOOI
Date Initiated2017-04-19
Date Terminated2017-10-20
Product Quantity15 units

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.

Firm Action

A recall notification letter was sent out on April 19, 2017. Prior to the recall letter being sent, the recalling firm sent a Customer Advisory Notification on April 14, 2017. The firm is also adding an accountability form to the customer notifications in order to document the customer responses to ensure that we account for the estimated 15 distributed units. For further questions, please call (877) 785-2323.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - US Distribution and to the countries of Finland and China.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162772ARIES GBS AssayLuminex Corporation · 2016-12-23K160517ARIES SystemLuminex Corporation · 2016-04-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑