Z-0536-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 16, 2020
- Initiation Date
- November 2, 2020
- Termination Date
- December 20, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200 packaging units
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.
Distribution Pattern
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.
Code Information
Order No. 75128, Lots No. 2219 (expiration 05/01/2022) and 2320 (expiration 06/01/2023)