Device 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.
Z-0536-2021
Product summary
- Event
- Event 86719
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 packaging units
- Official record key
device-enforcement:Z-0536-2021
Official wording
Reason: Products do not meet stability criteria and may impact results.
Code information: Order No. 75128, Lots No. 2219 (expiration 05/01/2022) and 2320 (expiration 06/01/2023)
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.