Reported Aug 31, 2016 · Terminated
Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance…
Tecan US, Inc.
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: Tecan US, Inc. · 9401 Globe Center Drive · Morrisville, NC · 27560
Is this the product you have?
- Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics.
- Lot codes and dates
26 of 26 products
Products covered by this recall # Product as published 1 CND5219H0B, Instrument Serial #1208002673 2 PC Serial numbers: CND44273RW, Instrument Serial #1211001074 3 PC Serial numbers: CND44273SC, Instrument Serial #1309006773 4 PC Serial numbers: 2CE3461RNR, Instrument Serial #1311008588 5 PC Serial numbers: 2CE33625KT, Instrument Serial #1401006356 6 PC Serial numbers: 2CE33626Q9, Instrument Serial #1403000833 7 PC Serial numbers: 2CE3461RR3, Instrument Serial #1403003928 8 PC Serial numbers: 2CE33625M4, Instrument Serial #1403005482 9 PC Serial numbers: 2CE41503JF, Instrument Serial #1405000420 10 PC Serial numbers: CND5219H4R, Instrument Serial #1405002510 11 PC Serial numbers: 2CE42406YJ, Instrument Serial #1406009472 12 PC Serial numbers: 2CE4220LGP, Instrument Serial #1410002321 13 PC Serial numbers: 2CE424072G, Instrument Serial #1410004940 14 PC Serial numbers: 2CE4240DJ7, Instrument Serial #1411008631 15 PC Serial numbers: 2CE424071M, Instrument Serial #1412005274 16 PC Serial numbers: CND44273XR, Instrument Serial #1503001536 17 PC Serial numbers: CND5219H1S, Instrument Serial #1503002986 18 PC Serial numbers: CND44262KJ, Instrument Serial #1503004890 19 PC Serial numbers: CND442625D, Instrument Serial #1501008506 20 PC Serial numbers: CND442627J, Instrument Serial #1501008513 - Amount recalled
- 5 units
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
The batteries have the potential to overheating, melt or char.
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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