Z-2153-2014Class II

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

Name: Z-2153-2014 Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a...
Creator: PerkinElmer Health Sciences, Inc.
Published: 2014-07-01
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2014-07-01 / Terminated / root cause: manufacturing process

FDA source

PerkinElmer Health Sciences, Inc. began a recall of 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... on 2014-07-01. FDA classified it as Class II and gives the reason as "Risk of incorrect results from samples prepared with Panthera-Puncher 9". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2153-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-01
Posted: 2014-08-06
Terminated: 2015-10-21
Recalling firm: Revvity Health Sciences, Inc.
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.
Product code: N/A
Reason for recall: Risk of incorrect results from samples prepared with Panthera-Puncher 9
Root cause tag: manufacturing process
FDA root cause: 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 [email protected]. 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.
Product codes and lots: Serial Numbers: 20810001 through 20810148

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2153-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2153-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-06

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)