Perkinelmer
Medical device manufacturer in Waltham, MA.
15510(k) clearances
0PMA approvals
22recalls
Device types
- MQB Solid State X-Ray Imager (Flat… 5
- NQL System, Test, Amino Acids, Free Carnitines… 3
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 1
- NAK System, Test, Biotinidase 1
- KQP Fluorescent Proc. (Qual.), Galactose-1-Phosp… 1
- PJC Newborn Screening Specimen Collection Paper 1
- PQW Alpha-D-Galactosidase A (Gla) Newborn… 1
- JIA Enzymatic Methods, Galactose 1
- PJI Severe Combined Immunodeficiency Disorder… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K203035 | Eonis SCID-SMA kitPJI · Traditional | 11/09/2022SE |
| K193103 | NeoBase 2 Non-derivatized MSMS KitNQL · Traditional | 02/07/2020SE |
| K190335 | GSP Neonatal Total Galactose kitJIA · Traditional | 11/06/2019SE |
| K190266 | NeoLSD MSMS KitPQW · Traditional | 05/03/2019SE |
| K161966 | PerkinElmer XRpad2 4336 HWC-M Flat Panel DetectorMQB · Special | 09/08/2016SE |
| K161942 | PerkinElmer, XRpad2 3025 HWC-M Flat Panel DetectorMQB · Special | 09/01/2016SE |
| K142698 | PerkinElmer, XRpad 4343 F MED Flat Panel DetectorMQB · Special | 10/23/2014SE |
| K140551 | Perkinelmer, Xrpad 4336 Med Flat Panel DetectorMQB · Traditional | 08/01/2014SE |
| K121864 | Perkinelmer 226 Sample Collection DevicesPJC · Abbreviated | 03/12/2013SE |
| K122495 | Perkinelmer XRD 1622 AP3 Med Flat Panel DetectorMQB · Traditional | 11/28/2012SE |
| K093916 | Neobase Non-Derivatized MSMS Kit Model 3040-001UNQL · Traditional | 08/23/2010SE |
| K100101 | GSP Neonatalgalt Kit, Model 3303-001UKQP · Traditional | 06/11/2010SE |
| K090123 | Neonatal Biotinidase Kit, Model 3018NAK · Traditional | 03/05/2010SE |
| K090846 | GSP Instrument and GSP Neonatal HTSH KitJLW · Traditional | 09/03/2009SE |
| K083130 | Neobase Non-Derivatized MSMS Kit, Model 3040NQL · Traditional | 07/09/2009SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0780-2017 Class II | PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with…Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for the tips. | 10/13/2016Terminated |
| Z-0747-2017 Class II | Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item…Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate… | 06/24/2016Terminated |
| Z-0638-2016 Class II | Perkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 The Wizard…The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second… | 12/08/2015Terminated |
| Z-0637-2016 Class II | Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 3470-0200. The…The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second… | 12/08/2015Terminated |
| Z-0636-2016 Class II | Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-0150 The…The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second… | 12/08/2015Terminated |
| Z-0635-2016 Class II | Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100. The…The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second… | 12/08/2015Terminated |
| Z-0634-2016 Class II | Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050. The…The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second… | 12/08/2015Terminated |
| Z-0633-2016 Class II | Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard gamma…The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second… | 12/08/2015Terminated |
| Z-0632-2016 Class II | Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard gamma…The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second… | 12/08/2015Terminated |
| Z-2130-2015 Class II | Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 The Wizard"…Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | 06/03/2015Terminated |
| Z-2129-2015 Class II | Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470-0200 The…Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | 06/03/2015Terminated |
| Z-2128-2015 Class II | Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The…Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | 06/03/2015Terminated |
| Z-2127-2015 Class II | Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 The…Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | 06/03/2015Terminated |
| Z-2126-2015 Class II | WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wizard" gamma…Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | 06/03/2015Terminated |
| Z-2125-2015 Class II | WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard" gamma counter is…Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | 06/03/2015Terminated |
| Z-2124-2015 Class II | Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard" gamma…Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | 06/03/2015Terminated |
| Z-0690-2013 Class II | Microplate, truncated V-bottomed lots included in the above listed products Product…Truncated V-Bottomed Microplate Wells used in assays contain defective wells. | 11/26/2012Terminated |
| Z-0689-2013 Class II | DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010Truncated V-Bottomed Microplate Wells used in assays contain defective wells. | 11/26/2012Terminated |
| Z-0688-2013 Class II | NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended…Truncated V-Bottomed Microplate Wells used in assays contain defective wells. | 11/26/2012Terminated |
| Z-0687-2013 Class II | NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass…Truncated V-Bottomed Microplate Wells used in assays contain defective wells. | 11/26/2012Terminated |
| Z-0686-2013 Class II | NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number:…Truncated V-Bottomed Microplate Wells used in assays contain defective wells. | 11/26/2012Terminated |
| Z-2121-2012 Class II | Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage:…Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for Genetic… | 06/27/2012Terminated |