The Recall Desk

Manufacturer

PerkinElmer Life and Analytical Sciences, Wallac, OY

9 recalls in our database name PerkinElmer Life and Analytical Sciences, Wallac, OY as the manufacturing or recalling firm.

What the numbers show

Total
9
Critical
0
Severe
2
Most recent
2019-05-08

Of the 9 recalls from PerkinElmer Life and Analytical Sciences, Wallac, OY we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (22%) 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.

1–9 of 9

  • ModerateFDA (Devices)·Z-1237-2019·2019-05-08

    PerkinElmer Recalls DELFIA hCG Kits Due to Measurement Inaccuracy

    PerkinElmer is recalling 31 DELFIA hCG Kits because hCG concentrations may be decreased by 15-20% at the lower measuring range.

    Product
    DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1239-2019·2019-05-08

    PerkinElmer AutoDELFIA hCG Kit Recalled for Inaccurate Low-Range Results

    PerkinElmer is recalling AutoDELFIA hCG Kits because hCG concentrations may be decreased by 15-20% at the lower measuring range.

    Product
    AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1238-2019·2019-05-08

    PerkinElmer AutoDELFIA hCG Kit Recalled for Potential Measurement Inaccuracy

    PerkinElmer is recalling AutoDELFIA hCG Kits because hCG concentrations may be decreased by 15-20% at the lower measuring range.

    Product
    AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1220-2018·2018-09-12

    AutoDELFIA Neonatal IRT Kit Recalled for Missing Quality Control Certificate Information

    PerkinElmer is recalling AutoDELFIA Neonatal IRT kits because missing quality control certificate information may delay reporting of IRT results.

    Product
    AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1692-2018·2018-05-16

    PerkinElmer Recalls NeoBase Succinylacetone Assay Solution Due to Leaking Vials

    PerkinElmer is recalling NeoBase Succinylacetone Assay Solution because leaking vials may cause minor allergic skin reactions if proper attire is not used.

    Product
    NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-1541-2018·2018-05-09

    PerkinElmer Specimen Gate Screening Center Software Recall for Data Errors

    PerkinElmer is recalling Specimen Gate Screening Center software due to potential errors in neonatal screening results, including false negatives and positives.

    Product
    Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn s
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1761-2017·2017-04-19

    PerkinElmer Recalls Specimen Gate Laboratory Software Due to Data Errors

    PerkinElmer is recalling 29 units of Specimen Gate Laboratory software due to a potential for errors in patient results. The software is used for processing laboratory data.

    Product
    Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-1107-2017·2017-02-08

    PerkinElmer Genetic Screening Processor Recalled for Corroding Axles

    PerkinElmer is recalling 24 Genetic Screening Processor instruments because defective ball bushing axles may corrode in humid conditions, risking contamination of sample wells.

    Product
    Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1108-2017·2017-02-08

    PerkinElmer Spare Disk Remover Module Recall Due to Corrosion Risk

    PerkinElmer is recalling Spare Disk Remover Modules because defective axles may corrode in humid conditions, potentially contaminating test plates.

    Product
    Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
    Category
    Medical Device
    Distribution
    4 states