Instrumentation Laboratory Recalls ACL TOP 700 LAS Analyzers for Carryover Issue
Instrumentation Laboratory is recalling 56 ACL TOP 700 LAS analyzers due to a potential carryover issue that can 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 involves a medical device with a defect that can cause inaccurate test results (shortened APTT clotting times), which poses a risk of harm to patients through potential misdiagnosis or treatment errors, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Instrumentation Laboratory Co. is recalling 56 units of the ACL TOP 700 LAS bench-top, fully automated, random access analyzer. The device is designed for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing. The recall covers units with serial numbers ranging from 08120100 (December 2008) to 13070172 (July 2013).
The recall is being issued because of a potential carryover issue on the instrument that can cause shortened APTT clotting times. 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 on how to address the issue.
The recalled product
- Product
- ACL TOP 700 LAS; PN 0000280030 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
- Manufacturer
- Instrumentation Laboratory Co.
- Affected units
- 56
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 (4)
- Start SN and Date: 08120100
- Dec 2008
- End SN and Date: 13070172
- July 2013
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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