Recall Z-1108-2021 ยท GFO Activated Partial Thromboplastin
Helena Laboratories, Corp.
Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.
| Date | Jan 5, 2021 |
| Status | Terminated |
| Reason | Intermittent potential for shorter than expected clot times. |
| Root cause | Under Investigation by firm |
| Action | On 01/05/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via email to it distributors informing them that this Recall has been identified due to the potential for shorter than expected clot times on abnormal patients and on abnormal controls on some cards from specific lots and the use of these products may include difficulty achieving abnormal control results in range and incorrectly low patient results. Distributors were instructed to: 1) Immediately examine their inventory and quarantine the specific product lots 2) If they have further distributed the affected pr |
| Quantity | 205 total kits |
| Distribution | Worldwide distribution - U.S. Nationwide distribution and the countries of Germany, Italy, Romania, Australia, Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.