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U.S. Department of Health and Human Services

Class 2 Device Recall PantheraPuncher 9 .

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  Class 2 Device Recall PantheraPuncher 9 . see related information
Date Initiated by Firm July 01, 2014
Date Posted August 06, 2014
Recall Status1 Terminated 3 on October 21, 2015
Recall Number Z-2153-2014
Recall Event ID 68686
Product Classification Panthera-Puncher 9 . - Product Code ooo
Product Panthera-Puncher 9 .

Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-well microtiter plate. The identification of the sample punched to a specific well of the plate is stored and carried on to the next instrument or the data is transferred to the LIMS.
Code Information Serial Numbers: 20810001 through 20810148 
Recalling Firm/
Manufacturer		 PerkinElmer Health Sciences, Inc.
940 Winter St
Waltham MA 02451-1457
For Additional Information Contact
781-663-6900
Manufacturer Reason
for Recall		 Risk of incorrect results from samples prepared with Panthera-Puncher 9
FDA Determined
Cause 2		 Process design
Action Perkin Elmer sent an Urgent Medical Device Recall letter dated July 1, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The Recall Letter delivered to the end customer by email facilitated through our Perkin Elmer Technical Support group located in Akron Ohio. Technical Support will be asked to make sure the customers receive the Recall Letter and implement the recommended precautions: "Removing the plates from the Panthera-Puncher 9 when not actively punching and processing samples in the instrument. "Opening the plate track hatch if plates must reside in the Panthera-Puncher 9 while the instrument is idle or in sleep mode. This will interrupt power to the ionizer and eliminate any ionizer impact on the plate wells. For further information, please contact your local Perkin Eimer representative or GSTechnicaiSupport@PerkinEimer.com. For further information please call (781) 663-6900.
Quantity in Commerce 144 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of : Canada, Australia, Brazil, China, Denmark, Great Britain, Italy, France, Mexico, Qatar and Korea.
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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