The Recall Desk

Hazard

Erroneous Results recalls

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

What the numbers show

Total
147
Critical
1
Severe
5
Most recent
2026-08-26

Of the 147 erroneous results recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (3%) 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 erroneous 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.

1–25 of 147

  • HighFDA (Devices)·Z-2973-2026·2026-08-26

    Beckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect

    Beckman Coulter is recalling DxC 500i Clinical Analyzer Modules due to a software defect that may cause erroneous patient test results.

    Product
    Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0584-2026·2025-12-03

    Blood lead test kits recalled over mislabeled calibration buttons

    Magellan Diagnostics is recalling 1,774 LeadCare II Blood Lead Test Kits because calibration buttons used in kitting were labelled with the wrong lot number.

    Product
    The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare¿ II Test Kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0571-2026·2025-11-26

    Blood tubes recalled after being manufactured without the gel separator

    Greiner Bio-One is recalling 1,980,000 Vacuette 8 ml serum separator tubes because some were manufactured without the gel separator, which could yield erroneous assay results.

    Product
    Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0491-2026·2025-11-19

    Oak mix allergen tests recalled over barcode orientation misreading tube positions

    Siemens Healthcare Diagnostics is recalling 34 units of IMMULITE 2000 Oak Mix Specific Allergen because barcode orientation causes the instrument to misread tube positions in the holder wedge.

    Product
    IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2026·2025-11-19

    Hematology analyzers recalled because saturation flags may not be applied

    Abbott Laboratories is recalling 833 Alinity hq Analyzers because a software issue means the system does not visibly flag results when saturation is present, which may give incorrect results.

    Product
    Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0492-2026·2025-11-19

    Allergy IgE universal kits recalled over barcodes misordering tubes in wedges

    Siemens Healthcare Diagnostics is recalling 2,802 units of the 3gAllergy Specific IgE Universal Kit because barcode orientation causes the instrument to misread tube positions.

    Product
    3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2); Siemens Material Number (SMN): 10380875; Catalog Number: L2KUN6;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0493-2026·2025-11-19

    Food allergen panels recalled over barcodes causing wrong tube scanning order

    Siemens Healthcare Diagnostics is recalling 28 units of Food Panel 3 Specific Allergen because barcode orientation causes the instrument to misread tube positions in the holder wedge.

    Product
    Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0366-2026·2025-11-05

    Parathyroid hormone assay recalled over falsely depressed results at low range

    Siemens Healthcare Diagnostics is recalling 3,318 units of the IMMULITE 2000 Intact PTH assay over the potential for falsely depressed patient results at the low end of the assay range.

    Product
    Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0413-2026·2025-11-05

    Blood glucose meters recalled over display segments that can misread values

    Trividia Health is recalling 601 Good Neighbor Pharmacy TRUE METRIX blood glucose meters over a display defect that can cause glucose values to be misread.

    Product
    Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0372-2026·2025-11-05

    Capillary blood tubes recalled for causing false positive lead test results

    ASP Global is recalling 4,272,858 SAFE-T-FILL capillary blood collection tubes because tubes made between July 2023 and February 2025 cause false positive results on LeadCare testing systems.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Self-sealing Cap, Purple, Model: 07 6013; SAFE-T-FILL Micro Capillary Blood Collection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0414-2026·2025-11-05

    Nasal test kits recalled after a false negative on a positive sample

    Cepheid is recalling 4,132 Xpert SA Nasal Complete kits after post-market half-time stability testing produced a false negative result for a positive sample type.

    Product
    Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0412-2026·2025-11-05

    Sample preparation systems recalled over incorrect dead volumes in instructions

    Beckman Coulter is recalling 108 CellMek SPS sample preparation systems because the instructions for use list incorrect dead volumes and the software does not rock Cassette E.

    Product
    CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0215-2026·2025-10-29

    Clinical analyzer modules recalled over dilution factor software anomaly affecting results

    Beckman Coulter is recalling 160 DxC 500i Clinical Analyzer modules over a software anomaly that may not apply user-specified manual dilution factors, risking false low or high results.

    Product
    DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0216-2026·2025-10-29

    Immunoassay analyzers recalled over dilution factor anomaly affecting patient results

    Beckman Coulter is recalling 571 DxI 9000 Access Immunoassay Analyzers over a software anomaly that may not apply user-specified manual dilution factors, risking false low or high results.

    Product
    DxI 9000 Access Immunoassay Analyzer, Part Number C11137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0107-2026·2025-10-15

    FlexLab X system recalled over unevaluated blood sample integrity function

    Inpeco is recalling one FlexLab X system because the Sample Integrity Module's hemolysis, icterus and lipemia function has not been evaluated by the FDA.

    Product
    FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2573-2025·2025-09-24

    Hematology analyzers recalled over erroneously high hemoglobin results in some samples

    UniCel DxH 690T Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.

    Product
    UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2572-2025·2025-09-24

    DxH 900 hematology analyzers recalled over erroneously high hemoglobin results

    UniCel DxH 900 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.

    Product
    UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2575-2025·2025-09-24

    DxH 600 hematology analyzers recalled over erroneously high hemoglobin results

    UniCel DxH 600 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.

    Product
    UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2574-2025·2025-09-24

    DxH 800 hematology analyzers recalled over erroneously high hemoglobin results

    UniCel DxH 800 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.

    Product
    UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2542-2025·2025-09-17

    Urinary protein assay recalled over falsely depressed patient and calibration results

    Atellica CH Urinary/Cerebrospinal Fluid Protein assay is recalled because of the potential for falsely depressed patient, quality control and calibration results, or delayed results. 11,811 units are affected.

    Product
    Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
    Category
    Medical Device
    Distribution
    Distributed nationwide