Recall Z-2578-2023 ยท GKP Instrument, Coagulation, Automated
Instrumentation Laboratory
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS Model Number: 000002800
| Date | Sep 12, 2023 (initiated Jul 13, 2023) |
| Status | Open, Classified |
| Reason | Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result |
| Root cause | Under Investigation by firm |
| Action | UPDATE: 10/16/23: Update relates to additional ACL TOP Family 50 Series instruments that were installed after the field notification was initiated (Phase I), but prior to inclusion of the notification instructions in start-up kits with new production. During the Installation process, Service field representatives will provide the titled Important Instruction, to the customer. The letter states the same instructions as provided in the Urgent Medical Device Correction Letter initially issued. __________________________________________________________________________ Werfen Issued Urgent Medica |
| Quantity | 2,068 kits US: 6,270 units OUS |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Finland, Ireland, Lithuania, Malta, Qatar, Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150877 | ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS Instrumentation Laboratory CO, Dec 13, 2015 |