Instrumentation Laboratory ACL TOP Analyzer Recalled for Fibrinogen Testing Errors
Instrumentation Laboratory is recalling ACL TOP analyzers because they may report abnormal fibrinogen levels as normal or vice versa, potentially affecting clinical decisions.
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 is classified as FDA Class II, and the hazard involves diagnostic errors in a medical device that could lead to adverse health consequences, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Instrumentation Laboratory Co. is recalling 1,074 units of the ACL TOP (Base) analyzer, part number 0000280000. The recall is due to a defect where low abnormal fibrinogen samples may be reported as normal, and high fibrinogen samples may be reported as low. This device is a benchtop, fully automated, random access analyzer used in hemostasis laboratories for coagulation and fibrinolysis testing.
The affected units were distributed worldwide, including the United States and numerous international locations, from November 2003 to November 2011. The serial number range for the recalled units is 03110101 through 11111174. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare facilities and laboratories using these analyzers should stop using the affected units and contact Instrumentation Laboratory for instructions on how to proceed. The recall is intended to prevent potential misdiagnosis or inappropriate treatment decisions resulting from inaccurate fibrinogen test results.
The recalled product
- Product
- Instrumentation Laboratory ACL TOP (Base) PN 0000280000 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
- 1,074
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 · diagnostic error
See all →- ModeratePhilips Ingenia MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- HighSiemens Immulite 2000 Syphilis Screen Recall for Negative Bias
FDA (Devices) · 2026-08-26
- HighSiemens Immulite 2000 Syphilis Screen Recalled for Negative Bias
FDA (Devices) · 2026-08-26
- HighPhilips CT Scanners Recalled Due to Bolus Tracking Trigger Issue
FDA (Devices) · 2026-08-05
- HighPhilips IQon Spectral CT Recalled Due to Automatic Scan Trigger Failure
FDA (Devices) · 2026-08-05
Similar recalls
- HighInstrumentation Laboratory Recalls ACL TOP Analyzers Due to 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 Recalls ACL TOP 700 Analyzers for Carryover Issue
FDA (Devices) · 2013-09-25
- HighInstrumentation Laboratory Recalls ACL TOP Coagulation Instruments
FDA (Devices) · 2014-07-23
- HighInstrumentation Laboratory Recalls ACL TOP 700 LAS Analyzers for Carryover Issue
FDA (Devices) · 2013-09-25
- HighInstrumentation Laboratory ACL TOP 500 CTS Recall for Carryover Issue
FDA (Devices) · 2013-09-25