FDA recall Z-0807-2018

Product

VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Reason for recall

VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored refrigerated for up to 6 months.

Distribution

Worldwide

Key facts

Status

Terminated

Initiation date

2017-07-10

Report date

2018-03-07

Termination date

2020-08-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Raritan, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0807-2018