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 t

Hazard

Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result

Details from the source

Reason for recall: Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Finland, Ireland, Lithuania, Malta, Qatar, Sweden. Quantity: 2,068 kits US: 6,270 units OUS Lot/code info: Model Names UDI (1)ACL TOP 550 CTS 08426950729242; (2)ACL TOP 750 CTS 08426950784067; (3)ACL TOP 350 CTS 08426950784081; (4) ACL TOP 750 08426950784074; (5) ACL TOP 750 LAS 08426950784050 (6) ACL TOP 970 CL 08430793045476 Software: 1)ACL TOP 550 CTS v6.3.0 or later; (2)ACL TOP 750 CTS v6.3.0 or later; (3)ACL TOP 350 CTS v6.3.0 or later; (4) ACL TOP 750 v6.3.0 or later; (5) ACL TOP 750 LAS v6.3.0 or later; (6) ACL TOP 970 CL Version 1.1.0 (OUS). UPDATE: 10/16/23 Affected Serial Number Range Start SN End SN ACL TOP 350 CTS 21113058 23074369; ACL TOP 550 CTS 21112046 23072623; ACL TOP 750 22010516 23060671; ACL TOP 750 CTS 21110860 23071015; ACL TOP 750 LAS 21120879 23071077

UPC codes

08426950729242, 08426950784067, 08426950784081, 08426950784074, 08426950784050, 08430793045476

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.