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

Date

Dec. 19, 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 The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.

Reason

Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected

Distribution pattern

US Distribution to state of TX and internationally to: Australia, Netherlands, Italy, and England.

Quantity

12 Kits

Codes and lots

Lot Codes: 1-15-5701 Model/Catalog Number: 5701

Recall started

April 20, 2016

Device type

Hemoglobin M

Root cause (FDA)

Device Design

What the company told customers

On 04/20/2016 the firm, Helena Laboratories, contacted affected users via email, and then sent a "WITHDRAWAL NOTIFICATION" (dated April 25, 2016) on 04/27/2016. The notification described the product, problem and actions to be taken. The firm instructed the customers/distributors to disposes of affected lot, as a preventive quality measure. The Withdrawal Notification for Removal of Product from Inventory stated, This lot is to be handled by Distributors, as follows: ___ Prevent any shipments or scheduled demonstrations with this lot ___ Remove this lot from Available Inventory and discard the cards ___ Place cards in Quarantine pending disposal ___ Contact International Sales for credit and delivery of replacement cards Verify amount REMOVED FROM STOCK: Total number pulled: ____________________ Date _____________________________ The following signifies written certification that this lot has not been sent to an end user: Verified by: _____________________________________________________________ Please complete this form and return a copy to Helena Laboratories, via: FAX: 409-842-1874 or e-mail to jjones@helena.com For questions, contact Mgr., Technical Services at: 1 (409) 842-3714 ext. 1177. *Reason for removal: Some cards in this lot are experiencing variations in wave form, resulting in possible shorter, or longer, times than expected. While this issue, if present, should be found via use of the Quality Control materials, due to its intermittent nature in the cards, this alone cannot be relied upon.

Recall number

Z-0594-2019

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

Source: FDA · Medical device enforcement report, recall number Z-0594-2019. The agency record governs; check it and the company before acting.