Meridian Bioscience Inc: Medical Device Recall in 2021 - (Recall #: Z-1299-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.

Product Classification:

Class II

Date Initiated: February 8, 2021

Date Posted: March 31, 2021

Recall Number: Z-1299-2021

Event ID: 87430

Reason for Recall:

Use of the kits after incorrect storage could lead to a potential false-negative or invalid result. In the event of a false-negative, the incorrect assumption would be made as to the cause of patient symptoms. The appropriate treatment may not be administered, and symptoms may progress. Additional evaluations will be completed and documented within the associated Health Hazard Evaluation.

Status: Terminated

Product Quantity: 8 kits

Code Information:

Catalog Number: 709030, Lot Number: 709030M114, Device Identifier: 00840733101762.

Distribution Pattern:

US Nationwide distribution in the states of OH, SC.

Voluntary or Mandated:

Voluntary: Firm initiated