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Instrumentation Laboratory recalls ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulati
Recalled September 20, 2023 · FDA recall Z-2578-2023 · Instrumentation Laboratory
Hazard
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result · FDA Class II
Units
2,068 kits US: 6,270 units OUS
Sold at
Worldwide distribution - US Nationwide and the countries of Canada, Finland, Ireland, Lithuania, Malta, Qatar, Sweden.
Description
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
Product
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: 00000280065; (4) ACL TOP 750 Model Number: 00000280015; (5) ACL TOP 750 LAS Model Number: 00000280035 (6) ACL TOP 970 CL(only available ROW)Model Number: 00000280097
Manufacturer(s)
Instrumentation Laboratory
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →