The Recall Desk
HighFDA (Devices)·Z-2153-2014·Announced 2014-08-13

PerkinElmer Recalls Panthera-Puncher 9 Sample Transfer Instruments

PerkinElmer is recalling 144 Panthera-Puncher 9 sample transfer instruments because they may produce incorrect results from dried blood samples.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk of incorrect results from a medical device, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

PerkinElmer Health Sciences, Inc. is recalling 144 units of the Panthera-Puncher 9 sample transfer instrument. The device is used in professional settings to extract dried blood disks from larger dried blood spots and transfer them to sample collection vessels, such as 96-well microtiter plates.

The recall is being issued because the instruments may produce incorrect results from the samples prepared with them. The affected units have serial numbers ranging from 20810001 through 20810148.

The recalled products were distributed nationwide in the United States and in Canada, Australia, Brazil, China, Denmark, Great Britain, Italy, France, Mexico, Qatar, and Korea. Users of these instruments should contact PerkinElmer Health Sciences, Inc. for instructions on how to proceed.

The recalled product

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-
Affected units
144

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Numbers: 20810001 through 20810148

Distribution

Distributed nationwide across the United States.