Reported Nov 11, 2015 · Terminated
ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method.…
ELITech Clinical Systems SAS
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: ELITech Clinical Systems SAS · Zone lndustrielle · SEES, N/A · N/A
Is this the product you have?
- ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following
- product reference numbers and namesGPSL-025O:
- Glucose PAP SL AUML-0250URIC
- ACID MONO SL CHSL-0250CHOLESTEROL SL
- TGML-0250TRIGLYCERIDES SL
- CRSL-0250CREATININE
- PAP SL HDLL-0230CHOLESTEROL
- HDL SL 2G LDLL-0230CHOLESTEROL LDL SL 2G
- Lot codes and dates
- all lots
- Amount recalled
- 969 systems
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
ELITech Clinical Systems reagents based on Trinder reaction used on the Selectra ProS and ProM systems are recalled due to potential drug interference. No complaints were received.
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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