Z-0537-2021 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
- 362 vials
Product Description
MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - 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. 0471, Lot No. 2019 (expiration 05/01/2022)