The Recall Desk

Manufacturer

PerkinElmer Health Sciences, Inc.

10 recalls in our database name PerkinElmer Health Sciences, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
10
Critical
0
Severe
0
Most recent
2020-06-10

Of the 10 recalls from PerkinElmer Health Sciences, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–10 of 10

  • LowFDA (Devices)·Z-2756-2017·2017-08-02

    PerkinElmer 226 Sample Collection Device Recalled for Labeling Mismatch

    PerkinElmer is recalling 226 Sample Collection Devices because pack label serial numbers did not match the devices inside.

    Product
    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.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1100-2017·2017-02-01

    PerkinElmer AutoDELFIA Plate Processor Recalled for Potential Loading Failures

    PerkinElmer is recalling AutoDELFIA Plate Processors with Version 3.0 software due to potential plate loading failures that could affect clinical assay results.

    Product
    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 a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1101-2017·2017-02-01

    PerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures

    PerkinElmer is recalling AutoDELFIA systems with Version 3.0 software due to potential plate loading failures that could affect clinical assay results.

    Product
    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 p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1102-2017·2017-02-01

    PerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures

    PerkinElmer is recalling AutoDELFIA systems with V3.0 software due to potential plate loading failures that could affect clinical assay results.

    Product
    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 an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0902-2017·2017-01-04

    PerkinElmer Recalls Specimen Gate Laboratory Software Due to Disk Space Issue

    PerkinElmer Health Sciences is recalling 21 units of Specimen Gate Laboratory and eReports software because a defect may cause excessive disk space consumption, leading to software failure.

    Product
    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 o
    Category
    Medical Device
    Distribution
    12 states
  • LowFDA (Devices)·Z-0779-2017·2016-12-28

    PerkinElmer Recalls DELFIA hFSH Kits Due to Stability Testing Failures

    PerkinElmer Health Sciences is recalling 79 DELFIA hFSH kits because real-time stability testing showed decreased hFSH concentrations in control sera.

    Product
    DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-0897-2017·2016-12-28

    PerkinElmer Recalls EnLite Neonatal TREC Kits for Missing UDI Labels

    PerkinElmer is recalling 73 EnLite Neonatal TREC Kits because the Unique Device Identifier (UDI) is missing from the outer box labels.

    Product
    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
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2153-2014·2014-08-13

    PerkinElmer Recalls Panthera-Puncher 9 Sample Transfer Instruments

    PerkinElmer is recalling 144 Panthera-Puncher 9 sample transfer instruments because they may produce incorrect results from dried blood samples.

    Product
    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-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2166-2014·2014-08-13

    PerkinElmer Specimen Gate Software Recalled for Data Mismatch Risk

    PerkinElmer is recalling Specimen Gate Screening Center software versions 1.4 and 1.6 due to a potential mismatch between demographic information and test results.

    Product
    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.
    Category
    Medical Device
    Distribution
    4 states