Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Recalled by Instrumentation Laboratory Due to Updated and revised user instructions issued 7/14/22. Potential...
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 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000280040 5. ACL TOP 500 CTS 00000280040R ( Refurbished) 6/ 6. ACL TOP 550 CTS 00000280045 7. ACL TOP 970 CL 00000280097
Quantity: 2725 units US: 5,572 units OUS.UPDATE: 2727 units US; 5277 units OUS
Why Was This Recalled?
Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine), specific to instrument models that utilize a single reagent probe
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