The Recall Desk

Manufacturer

Immunodiagnostics Systems Ltd

7 recalls in our database name Immunodiagnostics Systems Ltd as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2012-10-17

Of the 7 recalls from Immunodiagnostics Systems Ltd 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.

1–7 of 7

  • ModerateFDA (Devices)·Z-0044-2013·2012-10-17

    IDS-iSYS Intact PINP Assay Recalled for Incorrect IVD Labeling

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS Intact PINP assays because they were labeled for In Vitro Diagnostic use but are not registered for that purpose in the US.

    Product
    IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0039-2013·2012-10-17

    IDS Urine BETA CrossLaps ELISA Recalled for Incorrect IVD Labeling

    Immunodiagnostics Systems Ltd is recalling IDS Urine BETA CrossLaps ELISA kits because they were labeled for in vitro diagnostic use despite not being registered for that purpose in the US.

    Product
    IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps¿ ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0041-2013·2012-10-17

    IDS-iSYS Ostase BAP Control Set Recalled for Incorrect Labeling

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS Ostase BAP Control Sets because they are labeled as IVDs but are not registered for that use in the US.

    Product
    IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Ass
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0045-2013·2012-10-17

    IDS-iSYS Intact PINP Control Set Recalled for Incorrect IVD Labeling

    Immunodiagnostics Systems Ltd is recalling 29 units of IDS-iSYS Intact PINP Control Set because they were labeled as In Vitro Diagnostics (IVD) despite not being registered for that use in the US.

    Product
    IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the IDS-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0043-2013·2012-10-17

    IDS-iSYS N-Mid Osteocalcin Control Set Recalled for Labeling Errors

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS N-Mid Osteocalcin Control Sets because they were labeled as IVDs instead of Research Use Only.

    Product
    IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid¿ Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0040-2013·2012-10-17

    Immunodiagnostics Systems Recalls IDS-iSYS Ostase BAP Assay Due to Labeling Error

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS Ostase BAP assays because they were labeled for in vitro diagnostic use despite not being registered for that purpose in the US.

    Product
    IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0042-2013·2012-10-17

    IDS-iSYS Osteocalcin Assay Recalled for Incorrect IVD Labeling

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS N-Mid Osteocalcin assays because they were labeled as In Vitro Diagnostics (IVD) despite not being registered for that use in the US.

    Product
    IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Assay is intended for the quantitative determination of Osteocalcin in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Anal
    Category
    Medical Device
    Distribution
    Distributed nationwide