6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product U...
FDA Device Recall #Z-0521-2021 — Class II — October 29, 2020
Recall Summary
| Recall Number | Z-0521-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 29, 2020 |
| Status | Completed |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Chromsystems Instruments & Chemicals GmbH |
| Location | Grafelfing, N/A |
| Product Type | Devices |
| Quantity | 148 package units |
Product Description
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.
Reason for Recall
Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
Distribution Pattern
US Nationwide distribution in the states of NC and NY.
Lot / Code Information
Order No. 73039, Lot 3219 (expiration 08/01/2021) and Lot 1020 (Expiration 03/01/2022)
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| Z-1336-2022 | Class II | MassCheck Amino Acid, Acylcarnitines Dried Bloo... | May 19, 2022 |
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| 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 |
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.