Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES…

Date

Dec. 12, 2018

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Helena Laboratories, Inc.

Product

Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY

Reason

Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.

Distribution pattern

US: Products under control of Manufacturer in TX OUS: Four International Distributors - Australia, Netherlands, Italy, and England

Quantity

27 kits

Codes and lots

Lot Codes: 1-16-5701 Model/Catalog Number: 5701

Recall started

Feb. 24, 2017

Device type

Hemoglobin M

Root cause (FDA)

Device Design

What the company told customers

On 02/24/2017, the firm sent an email to affected users, with a Withdrawal Notification. The firm informed the customers/distributors that Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected. The firm instructed the customers/distributors to disposes of affected lot, as a preventive quality measure. On 04/12/2017, the firm mailed formal letters to all customers. PUBLIC CONTACT: "Name: Dr. Jessica Jones Hanka "Title: Technical Services Manager "Address: 1530 Lindbergh Drive, Beaumont, TX 77707 "Telephone #: (409) 842-3714 x1177 "Email: jhanka@helena.com

Recall number

Z-0561-2019

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0561-2019. The agency record governs; check it and the company before acting.