Reported Sep 26, 2012 · Terminated
Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer…
Instrumentation Laboratory Co.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Instrumentation Laboratory Co. · 180 Hartwell Road · Bedford, MA · 01730-2443
Is this the product you have?
- Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
- Lot codes and dates
- Serial Number range06020101
- through 10080662 Distributed betweenFeb 2006 to Aug 2010
- Amount recalled
- 562 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
This product could cause temporary or reversible health problems — stop using it.
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