FDA recall Z-2358-2023

ORTHO-CLINICAL DIAGNOSTICS · Class II · device

Product

VITROS Immunodiagnostic Products Troponin I ES Calibrators

Reason for recall

Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status
Ongoing
Initiation date
2023-06-05
Report date
2023-08-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bridgend, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2358-2023