CLASS II Device recall · Reported 13 Aug 2014 · FDA Enforcement Report
Panthera-Puncher 9 . Panthera-Puncher 9 is a sample recalled
PerkinElmer Health Sciences is recalling Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional, distributed nationwide in the US. The recall was initiated on 1 Jul 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2153-2014
- FDA event ID
- 68686
- Recalling firm
- PerkinElmer Health Sciences, Waltham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jul 2014
- FDA classified
- 6 Aug 2014
- Reported
- 13 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 1 Jul 2014 | Recall initiated by company | |
| 6 Aug 2014 | Classified by FDA | +36 days |
| 13 Aug 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Risk of incorrect results from samples prepared with Panthera-Puncher 9
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA (nationwide) and the countries of : Canada, Australia, Brazil, China, Denmark, Great Britain, Italy, France, Mexico, Qatar and Korea.
Questions about this recall
Why was it recalled?
Risk of incorrect results from samples prepared with Panthera-Puncher 9
Which lots are affected?
Serial Numbers: 20810001 through 20810148
Where was it sold?
Worldwide Distribution - USA (nationwide) and the countries of : Canada, Australia, Brazil, China, Denmark, Great Britain, Italy, France, Mexico, Qatar and Korea.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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