Instrumentation Laboratory Recalls ACL TOP Analyzers Due to Carryover Issue
Instrumentation Laboratory is recalling 929 ACL TOP analyzers because a potential carryover issue may cause shortened APTT clotting times.
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 a risk of harm (inaccurate diagnostic results) where specific injury or illness reports are not stated in the source text.
Plain-English summary
Instrumentation Laboratory Co. is recalling 929 ACL TOP (Base) bench-top analyzers, serial numbers 02110101 through 11111174, manufactured between November 2003 and November 2011. These devices are fully automated, random access analyzers designed for in vitro diagnostic clinical use in hemostasis laboratories for coagulation and fibrinolysis testing.
The recall is being conducted due to a potential carryover issue that can cause shortened APTT clotting times on the instrument. This defect may affect the accuracy of coagulation test results.
The affected units were distributed worldwide, including in the United States and numerous international locations. Users of these devices should contact Instrumentation Laboratory Co. for further instructions regarding the recall.
The recalled product
- Product
- ACL TOP (Base); PN 0000280000 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 thrombosis and/or hemostasis. The systems p
- Manufacturer
- Instrumentation Laboratory Co.
- Affected units
- 929
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Nov 2003 - Nov 2011
- Serial Numbers 02110101 through 11111174
Distribution
Part of a larger recall action
This product is one of 7 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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