Home / Recalls / PerkinElmer Health Sciences, Inc. / Z-1100-2017

Z-1100-2017 Class III Terminated

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

Recall Details

Product Type
Devices
Report Date
February 1, 2017
Initiation Date
December 21, 2016
Termination Date
October 3, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit (US) 6 (OUS)

Product Description

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

Reason for Recall

AutoDELFIA System with Version 3.0 Software: Potential plate loading failures

Distribution Pattern

Worldwide Distribution - US Nationwide in the state of MN and countries of China, India, Philippines, France, South Korea, Vietnam, Taiwan, Morocco, Kazachstan, UK, Spain, and Israel,

Code Information

AutoDELFIA¿ Plate Processor 1235-5110 UDI:(01)06438147334766, (21)2352016 Serial Number: 2352016 (US) Serial Numbers: OUS: s/n: 2352014, 2352046, 2352048,2352054, 2352056, 2352059

Other recalls by PerkinElmer Health Sciences, Inc.

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  • Z-2756-2017 Class III — PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collectio (May 31, 2017)
  • 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-0902-2017 Class II — Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software V (December 1, 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)