FDA recall Z-0678-2022

Product

meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.

Reason for recall

The product was incorrectly shipped at room temperature rather than refrigerated.

Distribution

US Distribution was made to IL, FL, LA, MS, NC, OH, and TX.

Key facts

Status

Terminated

Initiation date

2022-01-25

Report date

2022-03-02

Termination date

2023-01-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0678-2022