MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
FDA Device Recall #Z-1336-2022 — Class II — May 19, 2022
Recall Summary
| Recall Number | Z-1336-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 19, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Chromsystems Instruments & Chemicals GmbH |
| Location | Grafelfing, N/A |
| Product Type | Devices |
| Quantity | 1330 units |
Product Description
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Reason for Recall
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
Distribution Pattern
US: NY, OH, CT.
Lot / Code Information
Model: 0192; Lot Number: 2821; UDI/DI: 04250317502841
Other Recalls from Chromsystems Instruments & Chemicals ...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1337-2022 | Class II | MassCheck Amino Acid, Acylcarnitines Dried Bloo... | May 19, 2022 |
| Z-0537-2021 | Class II | MassChrom Amino Acid Analysis Plasma Control Le... | Nov 2, 2020 |
| Z-0536-2021 | Class II | 3PLUS1 Multilevel Plasma Calibrator Set, Order ... | Nov 2, 2020 |
| Z-0539-2021 | Class II | MassChrom Amino Acid Analysis Plasma Control Le... | Nov 2, 2020 |
| Z-0538-2021 | Class II | MassChrom Amino Acid Analysis Plasma Control Le... | Nov 2, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.