PerkinElmer Health Sciences

10 recalls •

• Categories: Other Medical Devices, Diagnostic Equipment, Surgical Instruments

PerkinElmer 226 Sample Collection Device

Class I - Dangerous

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.

Dec 19, 2017 Other Medical Devices View Details →

PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.

Class I - Dangerous

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.

May 31, 2017 Other Medical Devices View Details →

Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry

Class I - Dangerous

AutoDELFIA System with Version 3.0 Software: Potential plate loading failures

Dec 21, 2016 Diagnostic Equipment Nationwide View Details →

DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry

Class I - Dangerous

AutoDELFIA System with Version 3.0 Software: Potential plate loading failures

Dec 21, 2016 Diagnostic Equipment Nationwide View Details →

AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry

Class I - Dangerous

AutoDELFIA System with Version 3.0 Software: Potential plate loading failures

Dec 21, 2016 Diagnostic Equipment Nationwide View Details →

Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that functions to support newborn screening laboratories, hospitals, clinical and physicians in data management and generating reports

Class I - Dangerous

Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.

Dec 1, 2016 Other Medical Devices View Details →

DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum

Class I - Dangerous

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.

Nov 16, 2016 Diagnostic Equipment View Details →

EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR" EnLite instrument. The test is indicated for use as an aid in screening newborns for severe combined immunodeficiency disorder (SCID). Product Number: 3401-001U

Class I - Dangerous

Unique Device Identifier (UDI) is missing from outer kit box label.

Dec 5, 2016 Diagnostic Equipment View Details →

PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.

Class I - Dangerous

Potential for demographic information and test result to be mismatch.

Jun 27, 2014 Other Medical Devices View Details →

Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-well microtiter plate. The identification of the sample punched to a specific well of the plate is stored and carried on to the next instrument or the data is transferred to the LIMS.

Class I - Dangerous

Risk of incorrect results from samples prepared with Panthera-Puncher 9

Jul 1, 2014 Surgical Instruments Nationwide View Details →