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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The agency classified this as a Class II recall, and the hazard involves potential impact on diagnostic results for a medical device, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Chromsystems Instruments & Chemicals GmbH is recalling MassChrom Amino Acid Analysis Plasma Control Level I kits, Order No. 0471, Lot No. 2019 (expiration 05/01/2022). The recall involves 362 vials. The product is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
The recall was initiated because the products do not meet stability criteria and may impact results. The agency classified this as a Class II recall.
The product was distributed worldwide, including in the United States (California and New York), Australia, Belgium, Brazil, Germany, Finland, France, Greece, Israel, Italy, Canada, Croatia, Kuwait, Austria, Russia, Switzerland, South Africa, Taiwan, Turkey, and the United Arab Emirates. Users should stop using the affected product and contact the manufacturer for instructions.
The recalled product
- 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.
- Manufacturer
- Chromsystems Instruments & Chemicals GmbH
- Affected units
- 362
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Order No. 0471
- Lot No. 2019 (expiration 05/01/2022)
Distribution
Part of a larger recall action
This product is one of 4 recalled by Chromsystems Instruments & Chemicals GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Chromsystems Instruments & Chemicals GmbH
See all →- HighLaboratory Control Material Recalled for Insufficient Glycine Concentration
FDA (Devices) · 2022-07-13
- HighMedical Laboratory Control Material Recalled for Insufficient Glycine Concentration
FDA (Devices) · 2022-07-13
- HighChromsystems Recalls MassChrom Amino Acid Analysis Plasma Control Level III
FDA (Devices) · 2020-12-16
- ModerateChromsystems 3PLUS1 Multilevel Plasma Calibrator Set Recalled for Stability Issues
FDA (Devices) · 2020-12-16
- ModerateChromsystems Recalls MassChrom Amino Acid Analysis Plasma Control Level II
FDA (Devices) · 2020-12-16
Same hazard · mis labeling
See all →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02