Instrumentation Laboratory ACL TOP 500 CTS Recall for Carryover Issue
Instrumentation Laboratory is recalling ACL TOP 500 CTS analyzers due to a potential carryover issue that 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 involves a medical device with a defect that can lead to inaccurate diagnostic results (shortened APTT clotting times). Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Instrumentation Laboratory Co. is recalling 2,170 units of the ACL TOP 500 CTS bench top, fully automated, random access analyzer. The device is designed for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and fibrinolysis testing.
The recall is due to a potential carryover issue that can cause shortened APTT clotting times on the instrument. The affected units have serial numbers ranging from 08010100 to 13072599, manufactured between January 2008 and July 2013.
The devices were distributed worldwide, including in the United States and numerous international locations. The source text does not specify instructions for consumers or healthcare providers on how to proceed with the recall.
The recalled product
- Product
- ACL TOP 500 CTS; PN 0000280040 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
- 2,170
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 (1)
- Start SN and Date: 08010100 Jan 2008 - 13072599 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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