The Recall Desk

Hazard

Inaccurate Diagnostic Values recalls

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

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2016-06-22

Of the 2 inaccurate diagnostic values 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 inaccurate diagnostic values 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.

1–2 of 2

  • HighFDA (Devices)·Z-1945-2016·2016-06-22

    Sysmex XN-Series Hematology Analyzers Recalled for Potential Elevated Values

    Sysmex Corporation is recalling XN-10 and XN-20 hematology analyzers due to a potential for elevated hemoglobin and impedance platelet count values.

    Product
    The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-0193-2013·2012-11-14

    Clinical Diagnostic Solutions Recalls Boule Con Diff US Tri Pack Hematology Controls

    Clinical Diagnostic Solutions is recalling Boule Con Diff US Tri Pack hematology controls due to customer reports of inaccurate MCV and RDW% values.

    Product
    Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide