Recall Z-2153-2014— PerkinElmer Health Sciences, Inc.
Class II · Terminated
Class II FDA medical device recall by PerkinElmer Health Sciences, Inc., initiated 2014-07-01, terminated 2015-10-21. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Risk of incorrect results from samples prepared with Panthera-Puncher 9.
- Recalling firm
- PerkinElmer Health Sciences, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-01
- Terminated
- 2015-10-21
- Firm location
- Waltham, MA, United States
Product description
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.
Reason for recall
Risk of incorrect results from samples prepared with Panthera-Puncher 9
Data sourced from openFDA. This site is unofficial and independent of the FDA.