MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2022 - (Recall #: Z-0678-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 25, 2022

Date Posted: March 2, 2022

Recall Number: Z-0678-2022

Event ID: 89493

Reason for Recall:

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

Status: Terminated

Product Quantity: 19 kits

Code Information:

Lot numbers 750030M481, Exp. 4/29/2022; 750030N482, Exp. 12/2/2022; and 750030N483, Exp. 5/17/2023.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated