The Recall Desk

Manufacturer

Chromsystems Instruments & Chemicals GmbH

9 recalls in our database name Chromsystems Instruments & Chemicals GmbH as the manufacturing or recalling firm.

What the numbers show

Total
9
Critical
0
Severe
0
Most recent
2022-07-13

Of the 9 recalls from Chromsystems Instruments & Chemicals GmbH 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 listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

  • HighFDA (Devices)·Z-1337-2022·2022-07-13

    Laboratory Control Material Recalled for Insufficient Glycine Concentration

    Chromsystems has recalled MassCheck Amino Acid, Acylcarnitines dried blood controls (batch 2821) for insufficient glycine concentration. This may affect laboratory test accuracy.

    Product
    MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1336-2022·2022-07-13

    Medical Laboratory Control Material Recalled for Insufficient Glycine Concentration

    Chromsystems is recalling MassCheck Amino Acid Acylcarnitines dried blood spot control material due to too-low glycine concentration in batch 2821. The defect was found in units distributed to New York, Ohio, and Connecticut.

    Product
    MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0537-2021·2020-12-16

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0539-2021·2020-12-16

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0536-2021·2020-12-16

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0538-2021·2020-12-16

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0523-2021·2020-12-09

    Chromsystems Recalls MassChrom Cortisol and Cortisone Saliva Control Level II Kits

    Chromsystems is recalling MassChrom Cortisol, Cortisone Saliva Control Level II kits because control lots may not meet stability criteria, potentially causing increased results for patient cortisone samples.

    Product
    MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0521-2021·2020-12-09

    Chromsystems Saliva Calibrator Set Recalled for Stability Issues

    Chromsystems is recalling 6PLUS1 Multilevel Saliva Calibrator Sets because they may not meet stability criteria, potentially causing increased cortisone results in patient samples.

    Product
    6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0522-2021·2020-12-09

    Chromsystems Recalls MassChrom Cortisol Saliva Control Level I Vials

    Chromsystems is recalling 880 vials of MassChrom Cortisol, Cortisone Saliva Control Level I because the control lots may not meet stability criteria, potentially causing increased patient results.

    Product
    MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
    Category
    Medical Device
    Distribution
    Distributed nationwide