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Recall Observatory FDA recall evidence

Device 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.

Z-2153-2014

July 01, 2014

Class II

Product summary

Firm
PerkinElmer Health Sciences, Inc.
Event
Event 68686
Status
Terminated
Classification
Class II
Quantity
144 units
Official record key
device-enforcement:Z-2153-2014

Official wording

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

Code information: Serial Numbers: 20810001 through 20810148

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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