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PerkinElmer Health Sciences Recalls
10 recalls on record · August 13, 2014 to June 10, 2020 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 10, 2020Medical DevicesFDA
PerkinElmer Health Sciences, Inc. recalls PerkinElmer 226 Sample Collection Device
Hazard: PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.
August 2, 2017Medical DevicesFDA
PerkinElmer Health Sciences, Inc. recalls PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a med
Hazard: PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.
February 1, 2017Medical DevicesFDA
PerkinElmer Health Sciences, Inc. recalls DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1
Hazard: AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
February 1, 2017Medical DevicesFDA
PerkinElmer Health Sciences, Inc. recalls Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The
Hazard: AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
February 1, 2017Medical DevicesFDA
PerkinElmer Health Sciences, Inc. recalls AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac
Hazard: AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
January 4, 2017Medical DevicesFDA
PerkinElmer Health Sciences, Inc. recalls Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is
Hazard: Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.
December 28, 2016Medical DevicesFDA
PerkinElmer Health Sciences, Inc. recalls EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell
Hazard: Unique Device Identifier (UDI) is missing from outer kit box label.
December 28, 2016Medical DevicesFDA
PerkinElmer Health Sciences, Inc. recalls DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
Hazard: A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrated a decrease in hFSH concentrations between -4.8% to -11.3% for control sera. The -11.3% bias was observed at an hFSH target concentration of 101 IU/L. The change observed in the serum samples within the range 1.76 67.0 IU/L hFSH averaged -2.9%. The reference range of the assay spans 0.60 to 98.0 IU/L.
August 13, 2014Medical DevicesFDA
PerkinElmer Health Sciences, Inc. recalls PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Scree
Hazard: Potential for demographic information and test result to be mismatch.
August 13, 2014Medical DevicesFDA
PerkinElmer Health Sciences, Inc. recalls Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried b
Hazard: Risk of incorrect results from samples prepared with Panthera-Puncher 9