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.

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.

On 02/19/2021, Meridian issued an Urgent Medical Device Correction notice to customers via letter for ImmunoCard Mycoplasma kits from a specified lot. Upon receipt at the Cardinal Health Charlotte distribution center, the kits were identified to have a transit time of 115 hours with a maximum temperature of 55 F (approximately 12 C). This is beyond our transit time requirement of 72 hours and storage at 2-8 C. Cardinal placed the kits into a quarantine location, however 8 kits were inadvertently shipped to your facility.