Reported Aug 31, 2016 · Terminated
SUNRISE instrument. The INFINITE F50 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?
- SUNRISE instrument. The INFINITE F50 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
17 of 17 products
Products covered by this recall # Product as published 1 Instrument Material #16039400, PC Serial # 2CE4220L6Z, Instrument Serial # 1201008596 and Instrument Material #30087502, PC Serial #2CE3362777, Instrument Serial #1403008116 2 PC Serial #2CE3461RV1, Instrument Serial #1404001455 3 PC Serial #2CE3461RVY, Instrument Serial #1404001456 4 PC Serial #2CE41503MD, Instrument Serial #1405003467 5 PC Serial #2CE3462FX0, Instrument Serial #1405002373 6 PC Serial #2CE4220BW9, Instrument Serial #1407000866 7 PC Serial #2CE42406XP, Instrument Serial #1409007597 8 PC Serial #CND4426259, Instrument Serial #1412005606 9 PC Serial #CND442618S, Instrument Serial #1503003902 10 PC Serial #CND44261R2, Instrument Serial #1504007122 11 PC Serial #CND44273XJ, Instrument Serial #1504004857 12 PC Serial #CND5219GYY, Instrument Serial #1506006286 13 PC Serial #CND5219GYX, Instrument Serial #1509005071 14 PC Serial #CND5219H21, Instrument Serial #1511009478 15 PC Serial #CND5219GYN, Instrument Serial #1512005969 16 PC Serial #CND5219H68, Instrument Serial #1603000018 17 PC Serial #CND5219GYJ, Instrument Serial #1606001277 and PC Serial #CND5219GZW, Instrument Serial #1606001263. - Amount recalled
- 19 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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