FDA recall Z-2580-2024

Ortho-Clinical Diagnostics, Inc. · Class II · device

Product

VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2

Reason for recall

It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in "TM5-4MB" condition codes which lead to a delay of results.

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Sweden, United Kingdom.

Key facts

Status
Ongoing
Initiation date
2024-07-03
Report date
2024-08-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2580-2024