Instrumentation Laboratory Recalls ACL TOP CTS Coagulation Instruments
Instrumentation Laboratory is recalling 572 ACL TOP CTS automated coagulation laboratory instruments due to a potential for sample misidentification.
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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed incidents.
Plain-English summary
Instrumentation Laboratory Co. is recalling 572 units of the ACL TOP CTS, an automated coagulation laboratory instrument. The recall is being conducted because of a potential for sample misidentification. The affected units were distributed nationwide in the United States and internationally to numerous countries, including Canada, Mexico, and various nations in Europe, Asia, and South America.
The recall covers instruments with serial numbers ranging from 06020101 (manufactured in February 2006) to 10080662 (manufactured in August 2010). The source text does not specify the exact nature of the defect causing the misidentification or provide instructions for consumers on how to proceed. Users of these devices should contact the manufacturer for further information.
The recalled product
- Product
- ACL TOP CTS, automated coagulation laboratory instrument.
- Manufacturer
- Instrumentation Laboratory Co.
- Hazard
- Affected units
- 572
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: 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.
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