FDA recall Z-1834-2020

Product

VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468

Reason for recall

The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.

Distribution

US Nationwide. Australia, Bermuda, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, UK.

Key facts

Status

Terminated

Initiation date

2020-03-10

Report date

2020-05-06

Termination date

2022-09-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1834-2020