The Recall Desk

Hazard

Quality Control Error 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
2023-07-05

Of the 7 quality control error 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 quality control error 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-2022-2023·2023-07-05

    Immunoassay Quality Control Material Recalled for Out-of-Range Values

    Randox Laboratories is recalling Immunoassay Premium Control Tri Level quality control kits due to out-of-range values that caused delays in test result reporting. The affected lot was distributed to five states and Puerto Rico.

    Product
    Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2021-2023·2023-07-05

    FDA Recalls Immunoassay Quality Control Material for Out-of-Range Values

    Randox Laboratories has recalled a quality control product used in laboratory testing because control values are running outside their target ranges. This can delay when test results are reported.

    Product
    Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-1470-2020·2020-03-18

    Integra NeuraGen Nerve Guide Recalled for Quality Control Error

    Integra LifeSciences is recalling 55 units of NeuraGen Nerve Guides because nonconforming product was mistakenly released for commercial use.

    Product
    NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0844-2019·2019-02-27

    Ortho Vitros Myoglobin Calibrators Recalled for Stability Issues

    Ortho Clinical Diagnostics is recalling Vitros Myoglobin Calibrators due to a stability issue that may cause calibration failures or atypical quality control results.

    Product
    Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1603-2015·2015-05-20

    Biomerieux Recalls Vitek 2 Fungal Susceptibility Cards Due to QC Errors

    Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards because they produce Out-of-Range-Low Flucytosine QC results for Candida krusei. The affected products were distributed to foreign subsidiaries and distributors.

    Product
    Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instru
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1601-2015·2015-05-20

    Biomerieux Recalls Vitek 2 Fungal Susceptibility Cards Due to QC Errors

    Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards because they produced Out-of-Range-Low Flucytosine QC results for Candida krusei.

    Product
    Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instruc
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0639-2013·2013-01-16

    Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Errors

    Siemens Healthcare Diagnostics is recalling specific lots of Chek-Stix control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined resu
    Category
    Medical Device
    Distribution
    Distributed nationwide