The Recall Desk

Manufacturer

Phadia Ab

5 recalls in our database name Phadia Ab as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2024-01-31

Of the 5 recalls from Phadia Ab 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.

1–5 of 5

  • HighFDA (Devices)·Z-0783-2024·2024-01-31

    EliA GBM Diagnostic Wells Recalled for False Positive Results

    Phadia Ab recalls 124,928 EliA GBM Wells diagnostic kits distributed nationwide due to complaints of false positive results. The wells produced unexpected positive signals in samples tested without antigen.

    Product
    EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2397-2019·2019-09-04

    Phadia 1000 Immunodiagnostic Instruments Recalled for Liquid Sensor Error

    Phadia Ab is recalling 387 Phadia 1000 immunodiagnostic instruments due to a liquid sensor error. The recall affects facilities in 27 US states.

    Product
    Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1907-2019·2019-07-10

    Phadia EliA RF IgM Well Recalled for Potential Low Assay Results

    Phadia Ab is recalling EliA RF IgM Well kits due to a potential for reporting low assay results, which may affect rheumatoid arthritis diagnosis.

    Product
    EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1276-2018·2018-04-11

    Phadia Prime software recall for EliA assay retesting function

    Phadia Ab is recalling Phadia Prime software versions up to 2.1.4 to prevent the use of the 'OK to All' function when rejecting and retesting EliA assay samples.

    Product
    Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0697-2016·2016-02-03

    Phadia Recalls EliA SmDP Wells Due to Invalid Test Results

    Phadia Ab is recalling 76 units of EliA SmDP Well lot 0018 because nonspecific signals may cause incorrect positive or equivocal test results for systemic lupus erythematosus.

    Product
    EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) i
    Category
    Medical Device
    Distribution
    Distributed nationwide