Instrumentation Laboratory Recalls ACL TOP 700 Coagulation Instruments
Instrumentation Laboratory is recalling 633 ACL TOP 700 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 medical device with a potential for sample misidentification, which poses a risk of harm where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Instrumentation Laboratory Co. is recalling 633 units of the ACL TOP 700 automated coagulation laboratory instrument. The recall is being conducted because of a potential for sample misidentification. The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries.
The recall covers instruments with serial numbers ranging from 09080100 (dated August 2009) to 14050732 (dated May 2014). The source text does not specify the exact nature of the misidentification risk or any reported adverse events. Users of these instruments should contact Instrumentation Laboratory Co. for further instructions on how to proceed.
The recalled product
- Product
- ACL TOP 700, automated coagulation laboratory instrument.
- Manufacturer
- Instrumentation Laboratory Co.
- Hazard
- Affected units
- 633
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: 09080100 Aug 2009 and End SN and Date 14050732 May 2014
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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