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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Instrument Material #16039400, PC Serial # 2CE4220L6Z, Instrument Serial # 1201008596 and Instrument Material #30087502, PC Serial #2CE3362777, Instrument Serial #1403008116; PC Serial #2CE3461RV1, Instrument Serial #1404001455; PC Serial #2CE3461RVY, Instrument Serial #1404001456; PC Serial #2CE41503MD, Instrument Serial #1405003467; PC Serial #2CE3462FX0, Instrument Serial #1405002373; PC Serial #2CE4220BW9, Instrument Serial #1407000866; PC Serial #2CE42406XP, Instrument Serial #1409007597; PC Serial #CND4426259, Instrument Serial #1412005606; PC Serial #CND442618S, Instrument Serial #1503003902; PC Serial #CND44261R2, Instrument Serial #1504007122; PC Serial #CND44273XJ, Instrument Serial #1504004857; PC Serial #CND5219GYY, Instrument Serial #1506006286; PC Serial #CND5219GYX, Instrument Serial #1509005071; PC Serial #CND5219H21, Instrument Serial #1511009478; PC Serial #CND5219GYN, Instrument Serial #1512005969; PC Serial #CND5219H68, Instrument Serial #1603000018; PC Serial #CND5219GYJ, Instrument Serial #1606001277 and PC Serial #CND5219GZW, Instrument Serial #1606001263.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Tecan US, Inc.
- Reason for Recall:
- The batteries have the potential to overheating, melt or char.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
Instrument Material #16039400, PC Serial # 2CE4220L6Z, Instrument Serial # 1201008596 and Instrument Material #30087502, PC Serial #2CE3362777, Instrument Serial #1403008116; PC Serial #2CE3461RV1, Instrument Serial #1404001455; PC Serial #2CE3461RVY, Instrument Serial #1404001456; PC Serial #2CE41503MD, Instrument Serial #1405003467; PC Serial #2CE3462FX0, Instrument Serial #1405002373; PC Serial #2CE4220BW9, Instrument Serial #1407000866; PC Serial #2CE42406XP, Instrument Serial #1409007597; PC Serial #CND4426259, Instrument Serial #1412005606; PC Serial #CND442618S, Instrument Serial #1503003902; PC Serial #CND44261R2, Instrument Serial #1504007122; PC Serial #CND44273XJ, Instrument Serial #1504004857; PC Serial #CND5219GYY, Instrument Serial #1506006286; PC Serial #CND5219GYX, Instrument Serial #1509005071; PC Serial #CND5219H21, Instrument Serial #1511009478; PC Serial #CND5219GYN, Instrument Serial #1512005969; PC Serial #CND5219H68, Instrument Serial #1603000018; PC Serial #CND5219GYJ, Instrument Serial #1606001277 and PC Serial #CND5219GZW, Instrument Serial #1606001263.
Distribution:
Distributed in: US, AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2661-2016
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