FDA recall Z-0536-2021

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.

Reason for recall

Products do not meet stability criteria and may impact results.

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.

Key facts

Status

Terminated

Initiation date

2020-11-02

Report date

2020-12-16

Termination date

2021-12-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Grafelfing, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0536-2021