Instrumentation Laboratory Recalls ACL TOP CTS Analyzers Due to Carryover Issue
Instrumentation Laboratory is recalling 486 ACL TOP CTS 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 involves a medical device with a defect that can cause inaccurate test results (shortened APTT 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 486 units of the ACL TOP CTS bench top, fully automated, random access analyzer. The product is designed for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and fibrinolysis testing. The recall covers serial numbers from 06020101 (Feb 2006) to 10080662 (Aug 2010).
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 on how to address the issue.
The recalled product
- Product
- ACL TOP CTS; PN 0000280020 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
- 486
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: 06020101
- Feb 2006
- End SN and Date: 10080662
- Aug 2010
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.
See all 7 products in this recall →Related recalls
Same manufacturer · Instrumentation Laboratory Co.
See all →- HighInstrumentation Laboratory Recalls 722 ROTEM ex-tem Kits Due to Prolonged Clotting Times
FDA (Devices) · 2019-09-18
- HighInstrumentation Laboratory Recalls ROTEM ex-tem Kits Due to Prolonged Clotting Times
FDA (Devices) · 2019-09-18
- HighInstrumentation Laboratory Recalls ROTEM ex-tem Kits Due to Prolonged Clotting Times
FDA (Devices) · 2019-09-18
- ModerateInstrumentation Laboratory Recalls HemosIL ReadiPlasTin Diagnostic Reagent
FDA (Devices) · 2018-10-17
- ModerateInstrumentation Laboratory Recalls Hemosll ReadiPlasTin Kits Due to Performance Issues
FDA (Devices) · 2018-03-14
Same hazard · inaccurate results
See all →- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
- Highepoc BGEM BUN Test Card for epoc Blood Analysis System
FDA (Devices) · 2026-05-06
- HighAbbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results
FDA (Devices) · 2026-05-06