FDA recall Z-1308-2023

Product

MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above

Reason for recall

Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.

Distribution

not yet available

Key facts

Status

Ongoing

Initiation date

2023-02-01

Report date

2023-04-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Athens, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1308-2023