PerkinElmer, Inc
PerkinElmer, Inc appears in FDA public data with 22 recalls, 17 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0780-2017, Class II) was initiated on October 13, 2016. Its most recent 510(k) clearance was granted on November 9, 2022.
Summary
- Total Recalls
- 22
- 510(k) Clearances
- 17
- Inspections
- 1
- Compliance Actions
- 0
Known Names
perkinelmer, perkinelmer technologies gmbh and co kg, perkin-elmer, perkinelmer life and analytical sciences, wallac
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0780-2017 | Class II | PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with the: JANUS | October 13, 2016 |
| Z-0747-2017 | Class II | Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item Number: 60006 | June 24, 2016 |
| Z-0632-2016 | Class II | Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard gamma counter is in | December 8, 2015 |
| Z-0635-2016 | Class II | Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100. The Wizard gamma | December 8, 2015 |
| Z-0637-2016 | Class II | Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 3470-0200. The Wizard gam | December 8, 2015 |
| Z-0638-2016 | Class II | Perkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 The Wizard gamma counter | December 8, 2015 |
| Z-0634-2016 | Class II | Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050. The Wizard2 gam | December 8, 2015 |
| Z-0633-2016 | Class II | Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard gamma counter is in | December 8, 2015 |
| Z-0636-2016 | Class II | Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-0150 The Wizard gamma | December 8, 2015 |
| Z-2124-2015 | Class II | Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard¿" gamma counter | June 3, 2015 |
| Z-2126-2015 | Class II | WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wizard¿" gamma counter is | June 3, 2015 |
| Z-2127-2015 | Class II | Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 The Wizard¿" ga | June 3, 2015 |
| Z-2130-2015 | Class II | Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 The Wizard¿" gamma coun | June 3, 2015 |
| Z-2125-2015 | Class II | WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard¿" gamma counter is intended t | June 3, 2015 |
| Z-2128-2015 | Class II | Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The Wizard¿" g | June 3, 2015 |
| Z-2129-2015 | Class II | Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470-0200 The Wizard¿" g | June 3, 2015 |
| Z-0687-2013 | Class II | NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. Th | November 26, 2012 |
| Z-0689-2013 | Class II | DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010 | November 26, 2012 |
| Z-0690-2013 | Class II | Microplate, truncated V-bottomed lots included in the above listed products Product Number: | November 26, 2012 |
| Z-0688-2013 | Class II | NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029 | November 26, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| DEN200044 | Eonis SCID-SMA Kit | November 9, 2022 |
| K203035 | Eonis SCID-SMA kit | November 9, 2022 |
| K193103 | NeoBase 2 Non-derivatized MSMS Kit | February 7, 2020 |
| DEN180056 | GSP Neonatal Creatine Kinase - MM kit | December 12, 2019 |
| K190335 | GSP Neonatal Total Galactose kit | November 6, 2019 |
| K190266 | NeoLSD MSMS Kit | May 3, 2019 |
| K161966 | PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector | September 8, 2016 |
| K161942 | PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector | September 1, 2016 |
| K142698 | PerkinElmer, XRpad 4343 F MED Flat Panel Detector | October 23, 2014 |
| K140551 | PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR | August 1, 2014 |
| K121864 | PERKINELMER 226 SAMPLE COLLECTION DEVICES | March 12, 2013 |
| K122495 | PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR | November 28, 2012 |
| K093916 | NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U | August 23, 2010 |
| K100101 | GSP NEONATALGALT KIT, MODEL 3303-001U | June 11, 2010 |
| K090123 | NEONATAL BIOTINIDASE KIT, MODEL 3018 | March 5, 2010 |
| K090846 | GSP INSTRUMENT AND GSP NEONATAL HTSH KIT | September 3, 2009 |
| K083130 | NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 | July 9, 2009 |