Instrumentation Laboratory ACL TOP 500 CTS Analyzer Recalled for Fibrinogen Errors
Instrumentation Laboratory is recalling ACL TOP 500 CTS 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 provides inaccurate diagnostic results for a critical health parameter (fibrinogen), posing a risk of harm through misdiagnosis, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Instrumentation Laboratory Co. is recalling 2,171 units of the ACL TOP 500 CTS analyzer (PN 0000280040). 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 could lead to inaccurate assessment of thrombosis and hemostasis. The affected units have serial numbers ranging from 08010100 through 12062270 and were distributed between January 2008 and June 2012.
The devices were distributed worldwide, including the United States and numerous international countries. The FDA has classified this as a Class II recall. Users should contact Instrumentation Laboratory for instructions on how to address the issue.
The recalled product
- Product
- Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 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
- 2,171
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.
See all 6 products in this recall →Related recalls
Same manufacturer · Instrumentation Laboratory Co.
See all →- HighInstrumentation Laboratory Recalls 722 ROTEM ex-tem Kits Due to Prolonged Clotting Times
FDA (Devices) · 2019-09-18
- HighInstrumentation Laboratory Recalls ROTEM ex-tem Kits Due to Prolonged Clotting Times
FDA (Devices) · 2019-09-18
- HighInstrumentation Laboratory Recalls ROTEM ex-tem Kits Due to Prolonged Clotting Times
FDA (Devices) · 2019-09-18
- ModerateInstrumentation Laboratory Recalls HemosIL ReadiPlasTin Diagnostic Reagent
FDA (Devices) · 2018-10-17
- ModerateInstrumentation Laboratory Recalls Hemosll ReadiPlasTin Kits Due to Performance Issues
FDA (Devices) · 2018-03-14
Same hazard · mis diagnosis
See all →- SevereVolcano Corp Recalls Philips IntraSight Plus Systems Due to Data Error
FDA (Devices) · 2026-10-07
- HighBioporto ProNephro AKI Reagent Kit Recalled for Non-Validated Rework Process
FDA (Devices) · 2026-08-19
- HighFilmArray NGDS Warrior Panel Diagnostic Test Recalled Due to Strain Mismatch
FDA (Devices) · 2026-08-12
- HighDASH Rapid PCR Instrument Recalled Due to Software Issue Causing False Co-infection Results
FDA (Devices) · 2026-08-12
- HighDiagnostic Genetic Probe Recalled for Unexpected Chromosome Signals
FDA (Devices) · 2021-08-04
Similar recalls
- HighInstrumentation Laboratory ACL TOP 500 CTS Recall for Carryover Issue
FDA (Devices) · 2013-09-25
- HighInstrumentation Laboratory Recalls ACL TOP CTS Analyzers Due to Carryover Issue
FDA (Devices) · 2013-09-25
- HighInstrumentation Laboratory ACL TOP 700 CTS Analyzer Recall for Carryover Issue
FDA (Devices) · 2013-09-25
- HighInstrumentation Laboratory Recalls ACL TOP 700 Analyzers for Carryover Issue
FDA (Devices) · 2013-09-25
- HighInstrumentation Laboratory Recalls ACL TOP 700 LAS Analyzers for Carryover Issue
FDA (Devices) · 2013-09-25
- HighInstrumentation Laboratory ACL TOP 300 Analyzers Recalled for Carryover Issue
FDA (Devices) · 2013-09-25