Instrumentation Laboratory Recalls ACL TOP 700 Analyzers for Carryover Issue
Instrumentation Laboratory is recalling 311 ACL TOP 700 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 times), which poses a risk of harm through misdiagnosis or treatment errors, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Instrumentation Laboratory Co. is recalling 311 units of the ACL TOP 700 bench-top, fully automated, random access analyzer. These devices are 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. The affected units have serial numbers ranging from 09080100 to 13070559, manufactured between August 2009 and July 2013.
The devices were distributed worldwide, including in the United States and numerous international locations. Users of these devices should contact Instrumentation Laboratory for further instructions regarding the recall.
The recalled product
- Product
- ACL TOP 700; PN 0000280010 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 prov
- Manufacturer
- Instrumentation Laboratory Co.
- Affected units
- 311
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 (3)
- Start SN and Date: 09080100
- Aug 2009 End SN and Date: 13070559
- 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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