The Recall Desk

FDA (Devices) recall action 86699

Chromsystems Instruments & Chemicals GmbH recalled 3 products on 2020-12-09

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2020-12-09
Critical
0
Units
1,878

Why these products were recalled

Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

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

1–3 of 3

  • ModerateFDA (Devices)··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
    Distribution
    2 states
  • ModerateFDA (Devices)··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
    Distribution
    2 states
  • ModerateFDA (Devices)··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
    Distribution
    2 states