Cascade Abrazo aPTT Test Card…

Date

Oct. 9, 2019

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, Corp.

Product

Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.

Reason

Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.

Distribution pattern

Distribution was made to Germany and Australia. There was no U.S. distribution.

Quantity

21 kits

Codes and lots

Lot number 2-17-5722, Exp. 2018-09-30

Recall started

Dec. 7, 2017

Device type

Activated Partial Thromboplastin

Root cause (FDA)

Unknown/Undetermined by firm

What the company told customers

The recalling firm issued letters dated 11/12/2017 via email on 12/7/2017 explaining the issue and that they were doing a withdrawal of the lot.

Recall number

Z-2761-2019

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

Source: FDA · Medical device enforcement report, recall number Z-2761-2019. The agency record governs; check it and the company before acting.