FDA Enforcement
Class II
Terminated
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.
Recall: Z-0536-2021
·
Reported December 16, 2020
Enforcement
- Recall Number
- Z-0536-2021
- Event ID
- 86719
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Chromsystems Instruments & Chemicals GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 16, 2020
- Initiation Date
- November 2, 2020
- Classification Date
- December 4, 2020
- Termination Date
- December 20, 2021
- Address
- Am Haag 12, N/A, Grafelfing, N/A, N/A, Germany
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
Products do not meet stability criteria and may impact results.
Code Info
Order No. 75128, Lots No. 2219 (expiration 05/01/2022) and 2320 (expiration 06/01/2023)
Distribution
Worldwide distribution - US Nationwide distribution in the states of CA and NY; The countries of Australia, Belgium, Brazil, Germany, Finland, France, Greece, Israel, Italy, Canada, Croatia, Kuwait, Austria, Russia, Switzerland, South Africa, Taiwan, Turkey, and United Arab Emirates.
Quantity
200 packaging units