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Class 2 Device Recall Tecan Infinite M1000 PRO |
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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-2665-2016 |
| Recall Event ID |
74806 |
| Product Classification |
Colorimeter, photometer, spectrophotometer for clinical use - Product Code JJQ
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| Product |
Tecan Infinite M1000 PRO
The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity measurements, the Infinite M1000 PRO can also perform fluorescence polarization and luminescence measurements (including luminescence scans) as well as Amplified Luminescent Proximity Homogeneous Assays (AlphaScreen and AlphaLISA). The Infinite M1000 PRO is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite M1000 PRO is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards. |
| Code Information |
Instrument Material #30063849, PC Serial # 2CE3362609, Instrument Serial #1110008219; PC Serial # CND5219H33, Instrument Serial #1204007588; PC Serial # 2CE3462FTJ, Instrument Serial #1301009861; PC Serial # 2CE3462FTD, Instrument Serial #1311007574; PC Serial #2CE33625KP, Instrument Serial #1404000703; PC Serial #2CE33625ND, Instrument Serial #1404000704; PC Serial #2CE41503PY, Instrument Serial #1406000407; PC Serial #2CE41503NW, Instrument Serial #1408001415; PC Serial #2CE41503K0, Instrument Serial #1407003406; PC Serial #CND5219GY7, Instrument Serial #1509001006 and PC Serial #CND44273YB, Instrument Serial #1604003735. |
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 |
11 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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