Recall Z-0594-2019 ยท JPB Hemoglobin M
Helena Laboratories, Inc.
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.
| Date | Apr 20, 2016 |
| Status | Terminated |
| Reason | Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 12 Kits |
| Distribution | US Distribution to state of TX and internationally to: Australia, Netherlands, Italy, and England. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.