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.
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 recall is classified as FDA Class II, which indicates a situation that may cause temporary or medically reversible adverse health consequences. No specific injuries or illnesses are reported in the source text, placing it in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Chromsystems Instruments & Chemicals GmbH is voluntarily recalling 342 vials of MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473, Lot No. 2019. The product is a kit 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 on November 2, 2020, and classified as Class II by the FDA. The specific reason for the recall is not detailed in the provided source text. The affected product was distributed worldwide, including in the United States (California and New York) and numerous international locations such as Australia, Belgium, Brazil, Germany, and Canada.
The recall was terminated on December 20, 2021. Consumers and healthcare facilities should check their inventory for this specific lot number and expiration date (05/01/2022) and contact the manufacturer for instructions on return or disposal.
The recalled product
- 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.
- Manufacturer
- Chromsystems Instruments & Chemicals GmbH
- Affected units
- 342
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. 0473
- 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 MassChrom Amino Acid Analysis Plasma Control Level I Recalled
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 →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02