The Recall Desk

FDA (Devices) recall action 86719

Chromsystems Instruments & Chemicals GmbH recalled 4 products on 2020-12-16

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2020-12-16
Critical
0
Units
1,267

Why these products were recalled

XXX

Products do not meet stability criteria and may impact results.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2020-12-16

    Chromsystems Recalls MassChrom Amino Acid Analysis Plasma Control Level III

    Chromsystems Instruments & Chemicals GmbH is voluntarily recalling 342 vials of MassChrom Amino Acid Analysis Plasma Control Level III due to a Class II device defect.

    Product
    MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2020-12-16

    Chromsystems 3PLUS1 Multilevel Plasma Calibrator Set Recalled for Stability Issues

    Chromsystems is recalling 3PLUS1 Multilevel Plasma Calibrator Sets because they do not meet stability criteria, which may impact test results.

    Product
    3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2020-12-16

    Chromsystems MassChrom Amino Acid Analysis Plasma Control Level I Recalled

    Chromsystems Instruments & Chemicals GmbH is recalling MassChrom Amino Acid Analysis Plasma Control Level I kits because they do not meet stability criteria and may impact results.

    Product
    MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2020-12-16

    Chromsystems Recalls MassChrom Amino Acid Analysis Plasma Control Level II

    Chromsystems Instruments & Chemicals GmbH is voluntarily recalling 363 vials of MassChrom Amino Acid Analysis Plasma Control Level II due to a Class II device defect.

    Product
    MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
    Category
    Distribution
    2 states