Food, drugs, devices › Chromsystems Instruments & Chemicals GmbH
Device recall: MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Chromsystems Instruments & Chemicals GmbH (Grafelfing, N/A) initiated this device recall on 19 May 2022; FDA lists 2 product records under event 90266, classified Class II.
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. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 15 May 2024. 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
"Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products."
Distribution
"US: NY, OH, CT."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1336-2022 | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I | 1330 units | Class II | Terminated | 13 Jul 2022 |
| Z-1337-2022 | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II | 1457 units | Class II | Terminated | 13 Jul 2022 |
Context
Other enforcement events for Chromsystems Instruments & Chemicals GmbH
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 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 |
| 29 Oct 2020 | 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used a | Device | Class II | 3 |
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: "Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products."
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: NY, OH, CT."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 May 2024. "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.