Food, drugs, devices › Chromsystems Instruments & Chemicals GmbH
Device recall: 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used a
FDA enforcement event 86699 is a device recall by Chromsystems Instruments & Chemicals GmbH of Grafelfing, N/A, initiated 29 Oct 2020 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Completed. Initiation: voluntary: firm initiated. Chromsystems Instruments & Chemicals GmbH has 3 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Chromsystems Instruments & Chemicals GmbH, Grafelfing, N/A, Germany.
Reason for recall
"Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone."
Distribution
"US Nationwide distribution in the states of NC and NY."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0521-2021 | 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. | 148 package units | Class II | Completed | 9 Dec 2020 |
| Z-0522-2021 | 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. | 880 vials | Class II | Completed | 9 Dec 2020 |
| Z-0523-2021 | 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. | 850 vials | Class II | Completed | 9 Dec 2020 |
Context
Other enforcement events for Chromsystems Instruments & Chemicals GmbH
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 May 2022 | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I | Device | Class II | 2 |
| 2 Nov 2020 | 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic s | Device | Class II | 4 |
All 3 events for Chromsystems Instruments & Chemicals GmbH
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of NC and NY."
Is the recall still ongoing?
FDA lists the status as Completed. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.