The Recall Desk

Hazard

Imprecise Results recalls

7 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2020-08-12

Of the 7 imprecise results recalls 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 hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all imprecise results recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–7 of 7

  • ModerateFDA (Devices)·Z-2752-2020·2020-08-12

    Randox Lipase Assay Buffer Recalled for Imprecision in Quality Control

    Randox Laboratories is recalling specific batches of Lipase Colorimetric R1 Buffer due to confirmed imprecision in quality control and patient samples.

    Product
    Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2344-2018·2018-07-11

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products PHYT Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides due to a potential for imprecise results in quality control and patient samples.

    Product
    VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2690-2017·2017-07-12

    Beckman Coulter PrepPlus 2 Recalled for Sample Preparation Imprecision

    Beckman Coulter is recalling 473 PrepPlus 2 units because they may produce imprecise absolute counts in the first tube of a flow cytometry run.

    Product
    Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when used in combination with the COULTER TQPrep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVD applications on cleared Be
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0181-2014·2013-11-13

    Siemens Healthcare Recalls Emit 2000 Phenobarbital Assay Due to Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of the Emit 2000 Phenobarbital Assay because they may produce imprecise results. The recall covers units distributed in the US and Mexico.

    Product
    Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1107-2013·2013-04-24

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because extension springs may be out of specification, potentially causing imprecise test results.

    Product
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended for use in the measurement of a variety of chemistry analytes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1106-2013·2013-04-24

    Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS Chemistry Systems

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems because extension springs may be out of specification, potentially causing imprecise test results.

    Product
    VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished, Product Code 6801890. Intended for use in the measurement of a variety of chemistry analytes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1108-2013·2013-04-24

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated Systems

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because extension springs may be out of specification, potentially causing imprecise chemistry test results.

    Product
    VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement of a variety of chemistry analytes.
    Category
    Medical Device
    Distribution
    Distributed nationwide