Perkinelmer Health Sciences recalls
Perkinelmer Health Sciences appears in 10 official U.S. recall notices indexed by RecallRadar, most recently on 2020-06-10.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 10 |
|---|---|
| Published | 2014-08-13 to 2020-06-10 |
| By agency | FDA Device (10) |
| By classification | Class III (7), Class II (3) |
| By status | terminated (10) |
| Distribution named in notices | AK, AL, AZ, CA, CO, FL, GA, IL, KY, MA, MI, NJ, NV, NY, OH, SC, US, WA |
Recalls
- PerkinElmer 226 Sample Collection Device
FDA Device · Class III · 2020-06-10 · Perkinelmer Health Sciences
Reason: 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. - PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and tra…
FDA Device · Class III · 2017-08-02 · Perkinelmer Health Sciences
Reason: 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. - DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic…
FDA Device · Class III · 2017-02-01 · Perkinelmer Health Sciences
Reason: AutoDELFIA System with Version 3.0 Software: Potential plate loading failures - AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic i…
FDA Device · Class III · 2017-02-01 · Perkinelmer Health Sciences
Reason: AutoDELFIA System with Version 3.0 Software: Potential plate loading failures - Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA a…
FDA Device · Class III · 2017-02-01 · Perkinelmer Health Sciences
Reason: AutoDELFIA System with Version 3.0 Software: Potential plate loading failures - Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as…
FDA Device · Class II · 2017-01-04 · Perkinelmer Health Sciences
Reason: Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating. - DELFIA hFSH kit
FDA Device · Class III · 2016-12-28 · Perkinelmer Health Sciences
Reason: 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 tar… - EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision c…
FDA Device · Class III · 2016-12-28 · Perkinelmer Health Sciences
Reason: Unique Device Identifier (UDI) is missing from outer kit box label. - Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use
FDA Device · Class II · 2014-08-13 · Perkinelmer Health Sciences
Reason: Risk of incorrect results from samples prepared with Panthera-Puncher 9 - PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6
FDA Device · Class II · 2014-08-13 · Perkinelmer Health Sciences
Reason: Potential for demographic information and test result to be mismatch.