Instrumentation Laboratory ACL TOP 700 LAS Analyzer Recalled for Fibrinogen Errors
Instrumentation Laboratory is recalling ACL TOP 700 LAS 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall, and the defect involves significant diagnostic errors in a medical device that could lead to serious health consequences if clinical decisions are based on inaccurate data.
Plain-English summary
Instrumentation Laboratory Co. is recalling 46 units of the ACL TOP 700 LAS bench-top 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 08120100 through 12060145 and were distributed between December 2008 and June 2012. The devices were distributed worldwide, including the United States and numerous international countries. The agency has classified this as a Class II recall.
Healthcare facilities should contact Instrumentation Laboratory Co. for instructions on how to handle the affected devices. 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 700 LAS PN 0000280030 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
- 46
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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