Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ACL TOP Family 50 Series Models as follows: In vitro Recalled by Instrumentation Laboratory Due to Sample misidentification could occur under specific conditions and...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Instrumentation Laboratory directly.
Affected Products
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
Quantity: 2,068 kits US: 6,270 units OUS
Why Was This Recalled?
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Instrumentation Laboratory
Instrumentation Laboratory has 38 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report