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Class 2 Device Recall SUNRISE |
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Date Initiated by Firm |
July 25, 2016 |
Date Posted |
August 25, 2016 |
Recall Status1 |
Terminated 3 on January 23, 2017 |
Recall Number |
Z-2661-2016 |
Recall Event ID |
74806 |
Product Classification |
Colorimeter, photometer, spectrophotometer for clinical use - Product Code JJQ
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Product |
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 |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Tecan US, Inc. 9401 Globe Center Drive Suite 140 Morrisville NC 27560
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For Additional Information Contact |
Taunya Alexander 919-361-5200 Ext. 19519
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Manufacturer Reason for Recall |
The batteries have the potential to overheating, melt or char.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Tecan contacted all customers by Safety Announcement, via certified mail starting July 25, 2016. The letter identified the product, the problem, and the action to be taken by the customer. Because affected batteries pose a fire and burn hazard, it is extremely important that customers check whether their battery is affected. Customers were advised to go immediately to the HP Battery Recall website at: http://www.HP.com/go/batteryprogram2016 to check if their battery is affected by this recall. Customers were also advised to complete and return the Customer Response Form at QA@tecan.com or fax it to 919-287-2961.
Customers with questions should contact HP at 1-888-202-4320 or Tecan Technical Service's Helpdesk at 800-832-2687, option 1. |
Quantity in Commerce |
19 units |
Distribution |
Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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