Instrumentation Laboratory Recalls ACL TOP 700 CTS Coagulation Instruments
Instrumentation Laboratory is recalling 266 ACL TOP 700 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 high-risk medical device where sample misidentification could lead to incorrect patient care, but the source text does not report any specific injuries, illnesses, or deaths, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Instrumentation Laboratory Co. is recalling 266 units of the ACL TOP 700 CTS 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 countries across North America, South America, Europe, Asia, Africa, and Oceania. The serial numbers for the recalled units range from 09120101 (December 2009) to 14050368 (May 2014).
Healthcare facilities and laboratories should contact Instrumentation Laboratory Co. for instructions on how to handle the recalled instruments to prevent potential sample misidentification.
The recalled product
- Product
- ACL TOP 700 CTS, automated coagulation laboratory instrument.
- Manufacturer
- Instrumentation Laboratory Co.
- Hazard
- Affected units
- 266
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: 09120101 Dec 2009 End SN and Date 14050368 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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