Instrumentation Laboratory ACL TOP 700 CTS Recalled for Fibrinogen Test Errors
Instrumentation Laboratory is recalling ACL TOP 700 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 is classified as FDA Class II and involves a diagnostic error that could lead to incorrect clinical decisions, 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 140 units of the ACL TOP 700 CTS benchtop analyzer. The device is used 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.
The affected units have serial numbers ranging from 09120101 through 12060240 and were distributed between December 2009 and June 2012. The devices were distributed worldwide, including the United States and numerous international locations. The FDA has classified this recall as Class II.
Healthcare facilities should contact Instrumentation Laboratory for instructions on how to address the defect. The source text does not specify the exact corrective action or replacement protocol.
The recalled product
- Product
- Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 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
- 140
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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