Perkinelmer

FDA Regulatory Profile

Summary

Total Recalls
22
510(k) Clearances
17
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0780-2017Class IIPerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with the: JANUS October 13, 2016
Z-0747-2017Class IIPerkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item Number: 60006June 24, 2016
Z-0632-2016Class IIPerkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard gamma counter is inDecember 8, 2015
Z-0635-2016Class IIPerkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100. The Wizard gamma December 8, 2015
Z-0637-2016Class IIPerkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 3470-0200. The Wizard gamDecember 8, 2015
Z-0638-2016Class IIPerkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 The Wizard gamma counterDecember 8, 2015
Z-0634-2016Class IIPerkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050. The Wizard2 gamDecember 8, 2015
Z-0633-2016Class IIPerkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard gamma counter is inDecember 8, 2015
Z-0636-2016Class IIPerkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-0150 The Wizard gamma December 8, 2015
Z-2124-2015Class IIPerkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard¿" gamma counter June 3, 2015
Z-2126-2015Class IIWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wizard¿" gamma counter isJune 3, 2015
Z-2127-2015Class IIPerkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 The Wizard¿" gaJune 3, 2015
Z-2130-2015Class IIPerkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 The Wizard¿" gamma counJune 3, 2015
Z-2129-2015Class IIPerkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470-0200 The Wizard¿" gJune 3, 2015
Z-2125-2015Class IIWIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard¿" gamma counter is intended tJune 3, 2015
Z-2128-2015Class IIPerkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The Wizard¿" gJune 3, 2015
Z-0688-2013Class IINEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029November 26, 2012
Z-0690-2013Class IIMicroplate, truncated V-bottomed lots included in the above listed products Product Number: November 26, 2012
Z-0689-2013Class IIDBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010November 26, 2012
Z-0686-2013Class IINEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. November 26, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
DEN200044Eonis SCID-SMA KitNovember 9, 2022
K203035Eonis SCID-SMA kitNovember 9, 2022
K193103NeoBase 2 Non-derivatized MSMS KitFebruary 7, 2020
DEN180056GSP Neonatal Creatine Kinase - MM kitDecember 12, 2019
K190335GSP Neonatal Total Galactose kitNovember 6, 2019
K190266NeoLSD MSMS KitMay 3, 2019
K161966PerkinElmer XRpad2 4336 HWC-M Flat Panel DetectorSeptember 8, 2016
K161942PerkinElmer, XRpad2 3025 HWC-M Flat Panel DetectorSeptember 1, 2016
K142698PerkinElmer, XRpad 4343 F MED Flat Panel DetectorOctober 23, 2014
K140551PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTORAugust 1, 2014
K121864PERKINELMER 226 SAMPLE COLLECTION DEVICESMarch 12, 2013
K122495PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTORNovember 28, 2012
K093916NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001UAugust 23, 2010
K100101GSP NEONATALGALT KIT, MODEL 3303-001UJune 11, 2010
K090123NEONATAL BIOTINIDASE KIT, MODEL 3018March 5, 2010
K090846GSP INSTRUMENT AND GSP NEONATAL HTSH KITSeptember 3, 2009
K083130NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040July 9, 2009