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.
What this means for you
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 thr
- 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.
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