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.
Check against the official notice below — it lists the full affected range.
Meridian Bioscience Inc. is recalling 8 kits of the ImmunoCard Mycoplasma EIA test, which is designed to detect IgM antibodies to M. pneumoniae in serum to help diagnose recent Mycoplasma pneumoniae infection. The affected kits (Catalog Number 709030, Lot Number 709030M114) were distributed nationwide in Ohio and South Carolina. The recall was initiated because improper storage of the kits could result in false-negative or invalid test results.
If a false-negative result occurs, patients and healthcare providers could incorrectly determine the cause of symptoms, potentially delaying appropriate treatment and allowing symptoms to progress. The recall notice does not specify a remedy or required action for consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US Nationwide distribution in the states of OH, SC. Quantity: 8 kits Lot/code info: Catalog Number: 709030, Lot Number: 709030M114, Device Identifier: 00840733101762.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.