Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood

FDA device recall Z-2153-2014 · posted 2014-08-06 · Terminated

Recall details

Recalling firm

PerkinElmer Health Sciences, Inc.

Reason for recall

Risk of incorrect results from samples prepared with Panthera-Puncher 9

Action taken

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.

Root cause

Process design

Status

Terminated

Product code

N/A

Quantity affected

144 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of : Canada, Australia, Brazil, China, Denmark, Great Britain, Italy, France, Mexico, Qatar and Korea.

Date initiated

2014-07-01

Date posted

2014-08-06

Date terminated

2015-10-21

Location

Waltham, MA