ACL TOP CTS, automated coagulation laboratory instrument. (Instrumentation Laboratory Co.) – potential for sample misidentification (2014)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ACL TOP CTS, automated coagulation laboratory instrument.
Brand
Instrumentation Laboratory Co.
Lot Codes / Batch Numbers
Start SN and Date: 06020101 Feb 2006 End SN and Date 10080662 Aug 2010
Products Sold
Start SN and Date: 06020101 Feb 2006 End SN and Date 10080662 Aug 2010
Instrumentation Laboratory Co. is recalling ACL TOP CTS, automated coagulation laboratory instrument. due to Potential for sample misidentification.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for sample misidentification.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Mar 8, 2026