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.

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

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 [email protected] 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.