Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top Recalled by Instrumentation Laboratory Co. Due to Low Abnormal Fibrinogen Sample Reports as Normal 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 Co. directly.
Affected Products
Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Quantity: 562 units
Why Was This Recalled?
Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Instrumentation Laboratory Co.
Instrumentation Laboratory Co. has 31 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report