Device product
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.
Z-0537-2021
Product summary
- Event
- Event 86719
- Status
- Terminated
- Classification
- Class II
- Quantity
- 362 vials
- Official record key
device-enforcement:Z-0537-2021
Official wording
Reason: Products do not meet stability criteria and may impact results.
Code information: Order No. 0471, Lot No. 2019 (expiration 05/01/2022)
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.
Derived failure modes
-
Unknown
Products do not meet stability criteria and may impact results.