Instrumentation Laboratory Recalls ACL TOP 300 CTS Coagulation Instruments
Instrumentation Laboratory Co. is recalling ACL TOP 300 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 criteria for a High severity score.
Plain-English summary
Instrumentation Laboratory Co. is recalling 1,201 units of the ACL TOP 300 CTS automated coagulation laboratory instrument. The recall is due to a potential for sample misidentification.
The affected units were distributed worldwide, including nationwide in the United States and in numerous countries across North America, South America, Europe, Asia, Africa, and Oceania. The serial numbers for the recalled units range from 11110101 (November 2011) to 14051302 (May 2014).
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- Product
- ACL TOP 300 CTS, automated coagulation laboratory instrument.
- Manufacturer
- Instrumentation Laboratory Co.
- Hazard
- Affected units
- 1,201
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: 11110101 Nov 2011End SN and Date 14051302 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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