The Recall Desk

Hazard

Substrate Error recalls

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

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2022-01-05

Of the 6 substrate 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 substrate 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.

1–6 of 6

  • HighFDA (Devices)·Z-0428-2022·2022-01-05

    VIDAS procalcitonin diagnostic test substrate error causes testing delays

    Nationwide recall of VIDAS procalcitonin test kits for substrate defects that prevent testing and require retesting, potentially delaying diagnostic results.

    Product
    VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0429-2022·2022-01-05

    VIDAS Mumps IgG diagnostic test kit recalled due to substrate error

    bioMerieux is recalling one lot of VIDAS Mumps IgG diagnostic tests because a substrate error prevents the tests from running, causing delays.

    Product
    VIDAS Mumps IgG (MPG), REF 30218
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0439-2022·2022-01-05

    VIDAS SARS-COV-2 Diagnostic Test Recalled for Substrate Error

    bioMerieux is recalling two lots of VIDAS SARS-COV-2 IgG diagnostic tests due to substrate errors that prevent test execution, requiring users to repeat testing and potentially delaying results.

    Product
    VIDAS SARS-COV-2 IgG, Ref 423834-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0424-2022·2022-01-05

    FDA Recalls VIDAS PRG Progesterone Test Kits for Substrate Error

    bioMerieux is recalling 1,818 units of VIDAS PRG Progesterone test kits due to a substrate error that prevents the tests from running properly, causing delayed results when patients need repeat testing.

    Product
    VIDAS PRG Progesterone, REF 30409-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0427-2022·2022-01-05

    Diagnostic substrate error in medical testing device causes test failures

    bioMerieux is recalling 1,579 VIDAS DEX@ diagnostic devices due to substrate errors that prevent test execution, requiring users to rerun tests and potentially delaying results.

    Product
    VIDAS DEX@, Dimer Exclusion II, REF 30455-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0433-2022·2022-01-05

    VIDAS LH diagnostic test substrate error causes delayed results

    bioMerieux VIDAS LH test kits (lot 1008848600) are affected by a substrate error that prevents test execution, requiring users to repeat testing and potentially delaying results.

    Product
    VIDAS LH, REF 30406-01
    Category
    Medical Device
    Distribution
    Distributed nationwide