Reported Sep 25, 2013 · Terminated
ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer designed specifically for in vitro…
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?
- ACL TOP 700 CTS; PN 0000280050 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
- Start SN and Date
09120101Dec 2009
- End SN and Date
13070304July 2013
- Start SN and Date
- Amount recalled
- 185
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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