Reported Dec 26, 2018 · Terminated
Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography…
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
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: Clark Laboratories, Inc. (dba,Trinity Biotech USA) · 2823 Girts Rd · Jamestown, NY · 14701-9666
Is this the product you have?
- Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
- Lot codes and dates
- all serial numbers
- Amount recalled
- 372 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
lack of 510K
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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