Perkinelmer Life Sciences
Also registered as Perkinelmer Life Sciences, Inc.
Country not established
- Devices
- 2
- FDA recalls
- 12
At a glance
Market reach
- United States
- FDA recalls
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
- Regimes: De Novo Registry: De Novo
Neogram Pku Tandem Mass Spectrometry Kit Ref K021541
Regimes: 510(k) Registry: 510(k)
FDA recalls
Recalls initiated per year
- 2017 2
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 2 Aug 2017 Z-0728-2018 Class III Terminated We have become aware through internal testing that JANUS and Janus G3 Automated Workstations were failing production final acceptance testing due to a Horizontal Motion Error message displayed on the system. Further investigation concluded that two printed circuit boards (PCB) used in MDT models of Janus and Janus G3 were manufactured with the incorrect resistor values. This anomaly affects component part number 7101640 (PCB-Quad Motor Controller MDT) and part number 7101647 (PCB-Quad Motor Controller Gripper). This anomaly could result in the Horizontal Motion Error being displayed and result in instrument down time. Until PerkinElmer s corrective measures are completed, we request you; Be aware that there is potential for the Horizontal Motion Error message to display which could result in instrument down time. Follow guidance provided in the Janus Automated Workstation User Manual when the Horizontal Motion Error message displays. If you have additional questions, contact PerkinElmer Technical Support for further assistance (800) 762-4000.
- 15 May 2017 Z-2685-2017 Class II Terminated Potential for electric shock in the case of a failure to install the grommets, supplied with the system.
2015
- 24 Aug 2015 Z-0166-2016 Class II Terminated It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. The analytical test result value would be correct but the interpretation of the test result value would be incorrect.
2003
- 28 Jul 2003 Z-1206-03 Unclassified (pre-2012) Terminated Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples
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- 28 Jul 2003 Z-1207-03 Unclassified (pre-2012) Terminated Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples
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- 21 Jul 2003 Z-1140-03 Unclassified (pre-2012) Terminated Product's outer carton label was labeled with an extended expiration date
- 27 Jun 2003 Z-1139-03 Unclassified (pre-2012) Terminated The kits are producing lower values than expected, which may result in an increase of false positive test results.
- 30 May 2003 Z-0969-03 Unclassified (pre-2012) Terminated The device is not stable throughout its labeled expiration date.
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- 30 May 2003 Z-0970-03 Unclassified (pre-2012) Terminated The device is not stable throughout its labeled expiration date.
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- 30 May 2003 Z-0971-03 Unclassified (pre-2012) Terminated The device is not stable throughout its labeled expiration date.
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- 28 Jul 2003 Z-1206-03 Unclassified (pre-2012) Terminated Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples
Show all 12 recalls
2003
- 8 Jan 2003 Z-0898-03 Unclassified (pre-2012) Terminated The Control Cards are incorrectly labeled such that the normal 'N' and abnormal 'A' values are reversed.
2002
- 16 May 2002 Z-0973-03 Unclassified (pre-2012) Terminated The CSF Gels were manufactured incorrectly resulting in irregular wavy bands.
Frequently asked questions
How many devices does Perkinelmer Life Sciences have in the registry?
The registry currently lists 2 devices for Perkinelmer Life Sciences. Devices recorded under merged duplicate company entries are counted once.
Which registries list Perkinelmer Life Sciences's devices?
Among its 2 most recently registered devices, Perkinelmer Life Sciences has devices listed in FDA 510(k) (2 devices).
What risk classes do Perkinelmer Life Sciences's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Perkinelmer Life Sciences's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Perkinelmer Life Sciences?
FDA recall records list 12 recalls initiated by Perkinelmer Life Sciences, the most recent initiated on 2 Aug 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Perkinelmer Life Sciences in the registry?
The most recently registered devices listed for Perkinelmer Life Sciences include NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970 and NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT.