Recall Z-0536-2021— Chromsystems Instruments & Chemicals GmbH
Class II · Terminated
Class II FDA medical device recall by Chromsystems Instruments & Chemicals GmbH, initiated 2020-11-02, terminated 2021-12-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - 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.. Reason: Products do not meet stability criteria and may impact results..
- Recalling firm
- Chromsystems Instruments & Chemicals GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-02
- Terminated
- 2021-12-20
- Firm location
- Grafelfing, N/A, Germany
Product description
3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - 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.
Reason for recall
Products do not meet stability criteria and may impact results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.