Instrumentation Laboratory ACL TOP Analyzer Recalled for Fibrinogen Reporting Errors
Instrumentation Laboratory is recalling ACL TOP analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may provide inaccurate diagnostic results, posing a risk of harm through misdiagnosis or delayed treatment, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Instrumentation Laboratory Co. is recalling 562 units of the ACL TOP CTS analyzer (PN 0000280020). This bench-top, fully automated, random access analyzer is designed for in vitro diagnostic clinical use in hemostasis laboratories for coagulation and fibrinolysis testing.
The recall is due to a defect where low abnormal fibrinogen samples may report as normal, and high fibrinogen samples may report as low. This error could lead to inaccurate assessment of thrombosis and hemostasis.
The affected units were distributed worldwide between February 2006 and August 2010, including in the United States and numerous international countries. Serial numbers range from 06020101 through 10080662. Users should contact Instrumentation Laboratory for further instructions regarding the recall.
The recalled product
- Product
- 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…
- Manufacturer
- Instrumentation Laboratory Co.
- Affected units
- 562
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Instrumentation Laboratory Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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Similar recalls
- HighInstrumentation Laboratory Recalls ACL TOP CTS Analyzers Due to Carryover Issue
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- HighInstrumentation Laboratory ACL TOP 500 CTS Recall for Carryover Issue
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