Home / Recalls / PerkinElmer Health Sciences, Inc. / Z-2264-2020

Z-2264-2020 Class III Terminated

Recalled by PerkinElmer Health Sciences, Inc. — Greenville, SC

Recall Details

Product Type
Devices
Report Date
June 10, 2020
Initiation Date
December 19, 2017
Termination Date
March 26, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
164,952 devices

Product Description

PerkinElmer 226 Sample Collection Device

Reason for Recall

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.

Distribution Pattern

US distribution in the state of Ohio

Code Information

UDI: (01)50812589020011(17)200831(10)40020001; Serial Numbers: 06879601-06879700

Other recalls by PerkinElmer Health Sciences, Inc.

  • 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-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)