Home / Recalls / PerkinElmer Health Sciences, Inc. / Z-0902-2017

Z-0902-2017 Class II Terminated

Recalled by PerkinElmer Health Sciences, Inc. — Waltham, MA

Recall Details

Product Type
Devices
Report Date
January 4, 2017
Initiation Date
December 1, 2016
Termination Date
May 1, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
21

Product Description

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

Reason for Recall

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

Distribution Pattern

Worldwide Distribution - US including CO, FL, GA, IL, MA, MI, NV, NJ, OH, SC, AZ, KY and Internationally to Italy, Ireland, UK, Spain, and Peru

Code Information

Software Version 1.0

Other recalls by PerkinElmer Health Sciences, Inc.

  • Z-2264-2020 Class III — PerkinElmer 226 Sample Collection Device (December 19, 2017)
  • Z-2756-2017 Class III — PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collectio (May 31, 2017)
  • Z-1100-2017 Class III — AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 12 (December 21, 2016)
  • Z-1102-2017 Class III — DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1 (December 21, 2016)
  • Z-1101-2017 Class III — Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product N (December 21, 2016)
  • Z-0897-2017 Class III — EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-qua (December 5, 2016)
  • Z-0779-2017 Class III — DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum (November 16, 2016)
  • Z-2153-2014 Class II — Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for (July 1, 2014)
  • Z-2166-2014 Class II — PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Produc (June 27, 2014)